Tuesday, October 14, 2008

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Sat, 11 Oct 2008 00:44:51 -0500 (CDT)
Subject: The FDA this Week: Andy's Take -- FDA: Cough and Cold Medicines for Children

The FDA this Week: Andy's Take -- FDA: Cough and Cold Medicines for Children
Fri, 10 Oct 2008 22:57:00 -0500

As we approach the cold weather, you may see your kids sniffling more, having sore throats and stuffy noses. Choosing the appropriate remedy from a wide variety of over-the-counter medications is an important choice for parents. Over the past year there has been a lot of communication about whether or not these products should be used to treat children. The rules for marketing many of these products were developed many years ago. These rules do not always require that the products be studied in children to show whether they work for children but instead allow conclusions from experience of their effectiveness in adults.

My Take is that we must now understand scientifically that children are not just little adults. Current scientific standards must be used to assure these medications are effective and safe for your children in the correct prescribed dose to treat your child's cough and cold.

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 07:02:48 -0500 (CDT)
Subject: CDRH New Update

Center for Devices and Radiological Health, U.S. Food and Drug Administration

	FDA Home Page \| CDRH Home Page \| Search \| A-Z Index

Date: October 10, 2008

The following new items were added to the CDRH web pages on October 9, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recall Regulations

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 07:46:49 -0500 (CDT)
Subject: What's New at CBER Update

You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products - 10/9/2008

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 11:20:08 -0500 (CDT)
Subject: CFSAN Constituent Update October 10, 2008

* U.S. Food and Drug Administration *
* Center for Food Safety and Applied Nutrition *

CONSTITUENT UPDATE

Constituent Updates are also available on the web at http://www.cfsan.fda.gov/~dms/cfsupdat.html.

Announcing Availability of the new Employees FIRST Food Defense Awareness Training Kit for First-Line Employees

The U.S. Food and Drug Administration (FDA) in collaboration with the Center for Disease Control (CDC) and U.S. Department of Agriculture (USDA) will launch its food defense awareness training kit for First-Line Employees in the food and agriculture industry from farm to table. The FIRST training kit is the second in a line of Food Defense Awareness Materials. ALERT, a program that was issued in July 2006, also focuses on prevention and identifies key points that supervisors and managers in industry and businesses can use to raise awareness of food defense issues and decrease the risks of intention food contamination.

Employees FIRST is a food defense awareness initiative for employees that food industry management can include in their ongoing food defense training programs. FIRST will educate front-line industry workers from farm to table about the risk of intentional food contamination and the actions they can take to identify and reduce risks including:

F – FOLLOW company food defense plan and procedures
I – INSPECT your work area and surrounding areas
R – RECOGNIZE anything out of the ordinary
S – SECURE all ingredients, supplies and finished product
T – TELL management if you notice anything unusual or suspicious

Availability of Kit: Single copies of the kit will be available in English and Spanish. The kit is packaged in a self-mailer and it includes: 1 DVD; 4-color front and back poster in English and Spanish; and on-screen instructions for use. In addition, a web-ready version will be made available late October 2008. Copies of the kit may be obtained by ordering online from the Food Defense & Terrorism website (http://www.cfsan.fda.gov/fooddefense) or an email to marion.allen@fda.hhs.gov.

Contact: Marion V. Allen, Center for Food Safety and Applied Nutrition, Food Defense Oversight Team (HFS-007), Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: (301) 436-1584, email: marion.allen@fda.hhs.gov.

Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 14:08:40 -0500 (CDT)
Subject: What's New at CBER Update

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Supplement Approval: Antihemophilic Factor (Recombinant) Kogenate FS - Bayer HealthCare LLC.
Posted: 10/10/2008, Approval Date: 10/10/2008

Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 14:51:49 -0500 (CDT)
Subject: What's New at CBER Update

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FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A
Posted: 10/10/2008

Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 15:03:17 -0500 (CDT)
Subject: FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland

FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland
Fri, 10 Oct 2008 14:44:00 -0500

The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate.

Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 16:38:02 -0500 (CDT)
Subject: What's New at CBER Update

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Approval Information: C1 Esterase Inhibitor (Human) (CINRYZE) - Lev Pharmaceuticals, Inc.
Posted: 10/10/2008, Approval Date: 10/10/2008

FDA Licenses for Marketing New Therapy for Rare Genetic Disease
Posted: 10/10/2008

Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 08:02:48 -0500 (CDT)
Subject: Russell Stover Candies, Inc. Issues Hazelnut Allergy Alert for the 2 7/8 Oz Size Of Private Reserve Assorted Chocolates (October 9)

Russell Stover Candies, Inc. Issues Hazelnut Allergy Alert for the 2 7/8 Oz Size Of Private Reserve Assorted Chocolates (October 9)
Fri, 10 Oct 2008 07:40:00 -0500

The recalled product was distributed in the following states and cities: Texas, California, Louisiana, North Carolina, South Carolina, Virginia, Tennessee; Southaven, Mississippi; Billings, Montana; Sparks, Nevada; and Madison Heights, Michigan. An investigation determined 29 boxes of this candy may have been purchased by consumers, and up to another 188 boxes may have reached retail store locations. All the retail stores have been contacted to have the suspected product removed from the shelves.

Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 12:03:38 -0500 (CDT)
Subject: FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A

FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A
Fri, 10 Oct 2008 11:51:00 -0500

The U.S. Food and Drug Administration today approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia.

Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 14:03:15 -0500 (CDT)
Subject: Enforcement Report for October 8, 2008

Enforcement Report for October 8, 2008
Fri, 10 Oct 2008 12:52:00 -0500

Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 15:03:15 -0500 (CDT)
Subject: FDA Launches Food Defense Awareness Training Kit for Employees in the Food Industry

FDA Launches Food Defense Awareness Training Kit for Employees in the Food Industry
Fri, 10 Oct 2008 14:44:00 -0500

Today the U.S. Food and Drug Administration in collaboration with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture launched its food defense awareness training kit for first line food industry employees. The training targets these individuals because they can play an important role in helping to keep our nation's food supply safe, from the farm to the table.

Update : 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 17:03:09 -0500 (CDT)
Subject: FDA Licenses for Marketing New Therapy for Rare Genetic Disease

FDA Licenses for Marketing New Therapy for Rare Genetic Disease
Fri, 10 Oct 2008 16:05:00 -0500

The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States.

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 08:07:21 -0500 (CDT)
Subject: CDER New 10/8/2008

Center for Drug Evaluation and Research, U.S. Food and Drug Administration

October 8, 2008

Drugs@FDA Downloadable Data Files (updated)
New and Generic Drug Approvals
- Avelox (moxifloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
- Avelox In Sodium Chloride 0.8% In Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer Pharmaceuticals Corp., Labeling Revision
- Factive (gemifloxacin mesylate) Tablets, Oscient Pharmaceuticals Corp., Labeling Revision
- Floxin (ofloxacin) Tablets, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
- Levaquin (levofloxacin) Oral Solution, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
- Levaquin (levofloxacin) Tablets, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
- Levaquin In Dextrose 5% In Plastic Container (levofloxacin) Injection, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
- Noroxin (norfloxacin) Tablets, Merck & Co., Inc., Labeling Revision

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 08:12:50 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page \| CDRH Home Page \| Search \| A-Z Index

Date: October 9, 2008

The following new items were added to the CDRH web pages on October 8, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
	Federal Register: Medical Devices; Hearing Aids; Technical Data Amendments; Confirmation of Effective Date

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 08:48:57 -0500 (CDT)
Subject: What's New at CBER Update

You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Vacancy Announcement - Supervisory Medical Officer, DEB/OBE
Posted: 10/9/2008

Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 09:02:42 -0500 (CDT)
Subject: Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6)

Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6)
Thu, 09 Oct 2008 08:14:00 -0500

New York State Agriculture Commissioner alerted consumers not to eat Frozen Salted Croaker distributed by YS Trading Corp, Long Island City, New York because the product was uneviscerated. The Frozen Salted Croaker was sold in Hicksville, New York, Flushing, New York, and New Jersey in un-coded, unlabeled plastic bags.

Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 09:32:13 -0500 (CDT)
Subject: FDA Data Standards Update - SPL Xforms Update - Version 1.00

Greetings,

This e-mail serves as notification of the availability of version 1.00 of the SPL Xforms.

The SPL xforms are available on the Global Submit's website which is accessible via this hyperlink: http://www.fda.gov/oc/datacouncil/xforms.html.

Lonnie Smith
Project Manager

Structured Product Labeling Team

Medical Informatics Staff &

FDA Data Standards Council

Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 10:05:36 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Proposed and Final Rules Update

You are subscribed to CBER's Proposed and Final Rules for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

FEDERAL REGISTER: Distribution of Certain Drug Products by Registered Blood Establishments and Comprehensive Hemophilia Diagnostic Treatment Centers That Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements and Administrative Procedures, Final Rule -10/9/2008

Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 13:11:38 -0500 (CDT)
Subject: Drug Information Update- FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The Consumer Healthcare Products Association (CHPA), an association that represents most of the makers of nonprescription over-the-counter (OTC) cough and cold medicines in children, recently announced that its members are voluntarily modifying the product labels for consumers of OTC cough and cold medicines to state "do not use" in children under 4 years of age. Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products.

The U.S. Food and Drug Administration supports the voluntary actions by CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. The FDA continues to assess the safety and efficacy of these products and to revise its OTC monograph (list of approved ingredients and amounts) for these medicines. Although this new labeling is inconsistent with the current monograph, FDA will not object, under the circumstances presented here, to the new label modification stating "do not use in children under 4," which reflects a more restrictive use of the drugs in children.

The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist.

For more information, please visit: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01899.html

Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 04:03:05 -0500 (CDT)
Subject: FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children

FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children
Thu, 09 Oct 2008 03:14:00 -0500

The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist.

Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 09:02:38 -0500 (CDT)
Subject: Arnold Foods Company, Inc. Issues Allergy Alert on Undeclared Nuts in Brownberry Whole Grains Bread 100 Percent Whole Wheat (October 8)

Arnold Foods Company, Inc. Issues Allergy Alert on Undeclared Nuts in Brownberry Whole Grains Bread 100 Percent Whole Wheat (October 8)
Thu, 09 Oct 2008 08:14:00 -0500

The product being recalled has a green twist tie with a code date of "Oct 11" printed on the bread bag. No other Arnold brand or Brownberry brand products are affected.

Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 10:03:42 -0500 (CDT)
Subject: Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243

Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243
Thu, 09 Oct 2008 08:25:00 -0500

See Related information section for updated Letter from Mallinckrodt

Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 10:03:45 -0500 (CDT)
Subject: Consumer Alert: Undeclared Sulfites in Shad Raisins (October 6)

Consumer Alert: Undeclared Sulfites in Shad Raisins (October 6)
Thu, 09 Oct 2008 09:14:00 -0500

New York State Agriculture Commissioner alerted consumers that Fatima Brothers Inc. of Maspeth, New York is recalling Shad Raisins due to the presence of undeclared sulfites. The recalled Shad Raisins were packaged in uncoded, 7-ounce plastic bags. Shad Raisins were distributed in New York City.

Update : 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 13:03:36 -0500 (CDT)
Subject: Recalls and Melamine Contamination

Recalls and Melamine Contamination
Thu, 09 Oct 2008 12:44:00 -0500

FDA has increased inspections and product testing in response to the melamine contamination problem that originated in Chinese dairy products.

Update : 13
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 15:52:09 -0500 (CDT)
Subject: FDA MedWatch- OTC Cough and Cold Medicines- Product Labels Being Modified To State " Do Not Use" In Children Under 4 Years Of Age

FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state "do not use" in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns.

Read the entire 2008 MedWatch Safety Summaries, including a link to the FDA Press Release regarding the above issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#CoughCold

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 8 Oct 2008 07:38:19 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page \| CDRH Home Page \| Search \| A-Z Index

Date: October 8, 2008

The following new items were added to the CDRH web pages on October 7, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Summary Information for: Hoya iSpheric™ Model YA-60BB Intraocular Lens
	Summary Information for: XIENCE™ V Everolimus Eluting Coronary Stent System and PROMUS™ Everolimus Eluting Coronary Stent System

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 8 Oct 2008 08:32:40 -0500 (CDT)
Subject: FDA Warning Letters Update

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Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 8 Oct 2008 09:26:39 -0500 (CDT)
Subject: FDA Warning Letters Update

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Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 8 Oct 2008 13:47:12 -0500 (CDT)
Subject: What's New at CBER Update

You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 10/8/2008

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U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 06:50:23 -0500 (CDT)
Subject: What's New at CBER Update

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Untitled Letter: Antithrombin III, Human (Thrombate III), Talecris Biotherapies, Inc.
Posted: 10/7/2008

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 06:55:57 -0500 (CDT)
Subject: What's New at CBER Update

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Vacancy Announcement - Consumer Safety Officer, DRB/DBA/OBRR
Posted: 10/7/2008

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 07:44:03 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page \| CDRH Home Page \| Search \| A-Z Index

Date: October 7, 2008

The following new items were added to the CDRH web pages on October 6, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

CDRH Learn

Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 08:34:39 -0500 (CDT)
Subject: CDER New

October 6, 2008

Emergency Use Authorization (EUA) for the Pre-Event Provision and Potential Use of Doxycycline Hyclate Tablet Emergency Kits for Inhalational Anthrax
Inactive Ingredient Database (updated)
- Download
- Search
New and Generic Drug Approvals
- Bromocriptine Mesylate Tablets, Paddock Laboratories, Inc., Approval
- Exjade (deferasirox) Oral Suspension Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Galantamine Hydrobromide Extended-release Capsules , Barr Laboratories, Inc., Approval
- Hylenex[rDNA origin] (hyaluronidase [rDNA origin]) Injection, Halozyme Therapeutics Inc., Labeling Revision
- Nitrolingual (nitroglycerin) Spray, Sciele Pharma, Inc., Package Change

Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 11:42:49 -0500 (CDT)
Subject: What's New at CBER Update

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Draft Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Product (PDF - 125 KB)
Posted: 10/7/2008; Issued: 9/30/2008

Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 12:09:30 -0500 (CDT)
Subject: What's New at CBER Update

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PDUFA Pilot Project Proprietary Name Review; Concept Paper (PDF -295 KB)
Posted: 10/7/2008; Issued: 9/30/2008

Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 12:35:15 -0500 (CDT)
Subject: What's New at CBER Update

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Vacancy Announcement - Mathematical Statistician, OBE
Posted: 10/7/2008

Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 14:07:06 -0500 (CDT)
Subject: What's New at CBER Update

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Medical Device Notification (PSN-08-09) - Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc.
Posted: 10/7/2008, Recall Date: 9/30/2008

Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 14:08:22 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Recalls, Withdrawals, Field Corrections & Notifications Update

You are subscribed to CBER's Recalls, Withdrawals, Field Corrections & Notifications for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Medical Device Notification (PSN-08-09) - Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc. - 9/30/2008

Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 15:33:58 -0500 (CDT)
Subject: CDER New 10/7/2008

October 7, 2008

FDA issues an updated Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler). Information
Guidance for Industry: PDUFA Pilot Project: Proprietary Name Review (finalized) [PDF]
New and Generic Drug Approvals
- Arsenic Trioxide Injection, Teva Parenteral Medicines, Inc., Tentative Approval
- Cipro (ciprofloxacin) Injection, Bayer Pharmaceuticals Corp., Labeling Revision
- Cipro (ciprofloxacin) Oral Suspension, Bayer Pharmaceuticals Corp., Labeling Revision
- Cipro (ciprofloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
- Cipro In Dextrose 5% in Plastic Container (ciprofloxacin) Injection, Bayer Pharmaceuticals Corp., Labeling Revision
- Cipro XR (ciprofloxacin and ciprofloxacin hydrochloride) Extended-Release Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
- Flo-Pred (prednisolone acetate) Oral Suspension, Taro Pharmaceuticals, USA, Inc., Package Change
- Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
- Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision
- Olmesartan Medoxomil and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
- Primidone Tablets, Dr. Reddy's Laboratories, Ltd., Approval
- Relenza (zanamivir) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Warning Letter: YAZ (drospirenone and ethinyl estradiol) Tablets

Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 11:05:41 -0500 (CDT)
Subject: FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration

FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration
Tue, 07 Oct 2008 10:24:00 -0500

The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials.

Update : 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 13:02:46 -0500 (CDT)
Subject: FDA Approves Use of Temporary Pump to Assist Heart's Right Side

FDA Approves Use of Temporary Pump to Assist Heart's Right Side
Tue, 07 Oct 2008 12:48:00 -0500

The U.S. Food and Drug Administration approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart. Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart's left ventricle, which pumps oxygen-rich blood to the rest of the body. The CentriMag Right Ventricular Assist System is intended for patients requiring support for the heart's right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen.

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U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 6 Oct 2008 07:32:50 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page \| CDRH Home Page \| Search \| A-Z Index

Date: October 6, 2008

The following new items were added to the CDRH web pages on October 3, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Class I Medical Device Recall: Nebion, LLC HLX-8 Magnetic Resonance Device

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 6 Oct 2008 11:06:19 -0500 (CDT)
Subject: What's New at CBER Update

You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) Alphabetical List of Registered Establishments
Posted: 10/6/2008

Vacancy Announcement - Medical Officer, DVRPA/OVRR
Posted: 10/6/2008

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 6 Oct 2008 11:19:28 -0500 (CDT)
Subject: Mammography What's New Update

You are subscribed to Mammography What's New for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

"Medicare Improvements for Patients and Providers Act (MIPPA) of 2008" passed.

Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 6 Oct 2008 06:02:33 -0500 (CDT)
Subject: McCormick and Company Has Recalled McCormick Enchilada Sauce Mix Due To Unlabeled Milk Ingredients (September 30)

McCormick and Company Has Recalled McCormick Enchilada Sauce Mix Due To Unlabeled Milk Ingredients (September 30)
Mon, 06 Oct 2008 05:59:00 -0500

The McCormick Enchilada Sauce Mix was distributed to grocery stores nationally beginning on September 17, 2008. The product comes in 1.5 oz. pouches with an expiration date of "best by" AUG2910CH. The date is found printed in black on the back, bottom left of the pouch.

Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 6 Oct 2008 13:06:30 -0500 (CDT)
Subject: FDA Detects Melamine Contamination in Flavored Drink

FDA Detects Melamine Contamination in Flavored Drink
Mon, 06 Oct 2008 12:10:00 -0500

The U.S. Food and Drug Administration (FDA) has increased inspections and product testing efforts in response to the melamine contamination problem which originated in Chinese dairy products. As a result of the FDA's on-going testing program, the agency has detected melamine contamination in Blue Cat Flavor Drinks. The distributor of the product, Tristar Food Wholesale Co. Inc., initiated a recall of several flavors of Blue Cat Flavor Drink, based on the FDA's findings. The FDA advises the public not to consume this product and recommends that retailers and food service operators remove the product from sale or service.

Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 6 Oct 2008 13:06:33 -0500 (CDT)
Subject: FDA Detects Melamine Contamination in Flavored Drink

FDA Detects Melamine Contamination in Flavored Drink
Mon, 06 Oct 2008 12:10:00 -0500

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MedWatch - Tiotropium (Spiriva): updated information on risk of stroke and reports of cardiovascular adverse outcomes

Tiotropium (marketed as Spiriva HandiHaler)
Audience: Pulmonary care health professionals and patients
FDA informed healthcare professionals that FDA has reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease. The preliminary results reported by Boehringer Ingelheim to the FDA showed that there was no increased risk of stroke with tiotropium bromide compared to placebo.

Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Both studies examined cardiovascular outcomes.

FDA expects to receive the complete report for UPLIFT in November 2008. Results from this trial will also help to address some issues raised about tiotropium in the two recent publications. Due to the amount of data collected in UPLIFT, a complete review of the results could take several months, at which time FDA will update this communication with the final results of the UPLIFT analysis, as well as all the available data regarding tiotropium and stroke risk.

Read the complete MedWatch 2008 Safety summary, including a link both today's update and the original March 18th Early Communication, at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tiotropium

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Monday, October 13, 2008

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 07:26:35 -0500 (CDT)
Subject: Medtronic Neuromodulation INDURA Intrathecal Catheter Recall - Medical Device Safety

Medtronic has recalled it's Neuromodulation INDURA one-piece intrathecal catheters, sutureless pump connector revision kit, and intrathecal catheter pump segment revision kit. This is due to potential misconnections of the sutureless connector catheters and the catheter port on the pump.

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 08:02:56 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page \| CDRH Home Page \| Search \| A-Z Index

Date: October 3, 2008

The following new items were added to the CDRH web pages on October 2, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Consumer Information on: Akreos® Posterior Chamber Intraocular Lens - P060022
	Consumer Information on: COBAS TaqMan HBV Test For Use With The High Pure System - P050028
	Consumer Information on: Hoya iSpheric™ Model YA-60BB Intraocular Lens - P080004

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 11:04:15 -0500 (CDT)
Subject: Oncology Drugs Update

FDA Approves Alimta Injection for Treatment of Metastatic Non-Aquamous Non-Small Cell Lung Cancer (NSCLC).
More information: http://www.fda.gov/cder/Offices/OODP/whatsnew/Alimta.htm

FDA approves iobenguane I 123 injection for the detection of primary or metastatic pheochromocytoma or neuroblastoma.
More information: http://www.fda.gov/cder/Offices/OODP/whatsnew/iobenguane_I_123.htm

Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 12:21:07 -0500 (CDT)
Subject: What's New at CBER Update

You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Public Workshop: Workshop to Consider Approaches to Reduce the Risk of Transfusion-Transmitted Babesiosis in the United States – Transcript
Posted: 10/3/2008

Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 14:13:09 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Recalls, Withdrawals, Field Corrections & Notifications Update

You are subscribed to CBER's Recalls, Withdrawals, Field Corrections & Notifications for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Recall of m2000sp Instrument - Abbott Molecular, Inc. - 8/25/2008

Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 14:17:55 -0500 (CDT)
Subject: Medical Device Recalls: Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters

You are subscribed to Medical Device Recalls for U.S. Food & Drug Administration (FDA). Information about the Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters Class I Recall has recently been updated, and is now available.

Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 14:19:24 -0500 (CDT)
Subject: Recent Device Approvals: Hoya iSpheric™ Model YA-60BB Intraocular Lens

You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about the Hoya iSpheric™ Model YA-60BB Intraocular Lens (P080004) has recently been posted to the FDA website, and is now available.

Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 14:26:49 -0500 (CDT)
Subject: Recent Device Approvals: Akreos® Posterior Chamber Intraocular Lens

You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about the Akreos® Posterior Chamber Intraocular Lens has recently been posted to the FDA website, and is now available.

Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 14:27:37 -0500 (CDT)
Subject: Recent Device Approvals: COBAS TaqMan HBV Test For Use With The High Pure System

You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about the COBAS TaqMan HBV Test For Use With The High Pure System has recently been posted to the FDA website, and is now available.

Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 15:06:06 -0500 (CDT)
Subject: Medical Device Recalls: Nebion HLX-8 Magnetic Resonance Device

You are subscribed to Medical Device Recalls for U.S. Food & Drug Administration (FDA). Information about the Nebion HLX-8 Magnetic Resonance Device Class I Recall has recently been updated, and is now available.

Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 15:19:03 -0500 (CDT)
Subject: Nebion HLX-8 Magnetic Resonance Device Recall - Medical Device Safety Update

Nebion LLC has recalled the HLX-8 Magnetic Resonance Device because the device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices.

Update : 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 09:02:58 -0500 (CDT)
Subject: FDA Issues Interim Safety and Risk Assessment of Melamine and Melamine-related Compounds in Food

FDA Issues Interim Safety and Risk Assessment of Melamine and Melamine-related Compounds in Food
Fri, 03 Oct 2008 08:10:00 -0500

The U.S. Food and Drug Administration (FDA) today issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.

Update : 13
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 14:05:52 -0500 (CDT)
Subject: Tristar Food Wholesale Co Inc. Issues a Nationwide recall of Blue Cat Flavor Drink Because of Possible Health Risk (October 3)

Tristar Food Wholesale Co Inc. Issues a Nationwide recall of Blue Cat Flavor Drink Because of Possible Health Risk (October 3)
Fri, 03 Oct 2008 13:44:00 -0500

Tristar Food, Jersey City, NJ is initiating a nationwide recall of all of their 100 ml plastic bottle packages of Blue Cat Flavor Drink (Lanmao) because it may be contaminated with Melamine.

Update : 14
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 15:24:50 -0500 (CDT)
Subject: FDA MedWatch- Nebion HLX-8 Magnetic Resonance Device: Device Not Approved By FDA

FDA notified healthcare professionals of a Class I Recall of the Nebion HLX-8 Magnetic Resonance Device. The manufacturer of the device made unsupported claims that the product could be used to treat many different medical conditions and diseases such as cancer (including breast, bone, lung, and pancreatic), carpel tunnel syndrome, migraines, premenstrual syndrome, rheumatoid arthritis, ruptured disks, shingles, and sports injuries and sprains. The device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device.

Read the entire 2008 MedWatch Safety Summaries, including a link to the FDA Class I Recall notice regarding the above issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Nebion

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U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 2 Oct 2008 07:46:15 -0500 (CDT)
Subject: CDER New 10/1/2008

October 1, 2008

Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
Drugs Shortages: Drugs to be Discontinued: SecreFlo (porcine secretin for injection, 16 mcg/vial) (updated)
New and Generic Drug Approvals
- Cyclobenzaprine Hydrochloride Tablets, Aurobindo Pharma USA, Inc., Approval
- Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Promethazine Hydrochloride Injection, Wockhardt USA, Inc., Approval
- Stalevo (carbidopa and entacapone and levodopa) Tablets, Orion Corp., Labeling Revision
- Tramadol Hydrochloride and Acetaminophen Tablets, Alphapharm Party, Ltd., Approval
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
Paragraph IV Patent Certifications (updated)

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 2 Oct 2008 07:50:36 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page \| CDRH Home Page \| Search \| A-Z Index

Date: October 2, 2008

The following new items were added to the CDRH web pages on October 1, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Class I Medical Device Recall: Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit
	Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Written Comments
	Registration and Listing (Device Establishment Registration and Listing for FY2009 Now Available)

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 2 Oct 2008 15:05:27 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Recalls, Withdrawals, Field Corrections & Notifications Update

You are subscribed to CBER's Recalls, Withdrawals, Field Corrections & Notifications for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Medical Device Notification: m2000sp Instrument - Abbott Molecular, Inc. - 8/25/2008

Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 2 Oct 2008 16:19:32 -0500 (CDT)
Subject: CDER New 10/2/2008

October 2, 2008

Drugs@FDA Downloadable Data Files (updated)
Guidance for Industry: Comprehensive List of Guidance Documents
Guidance for Industry: New/Revised/Withdrawn List for 2008
Investigational Human Drugs: Clinical Investigator Inspection List (updated)
- Search
- Download
New and Generic Drug Approvals
- Curosurf (poractant alpha) Intratracheal Suspension, Dey, L.P., Labeling Revision
- Didanosine Delayed-Release Capsules, Aurobindo Pharma, Approval
- EpiPen and Epi E Z Pen Jr (epinephrine) Intramuscular Injection, Meridian Medical Technologies Inc., Labeling Revision
- Exubera (insulin human [rDNA origin]) Inhalation Powder, Labeling Revision
- Reyataz (atazanavir sulfate) Capsules, Bristol-Myers Squibb Co., Patient Population Altered
- Videx Ec (didanosine) Delayed Release Capsules, Bristol-Myers Squibb Co., Patient Population Altered
Warning Letter: Mirapex (pramipexole dihydrochloride)

Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 2 Oct 2008 08:02:47 -0500 (CDT)
Subject: Lion Pavilion Issues Alert on Undeclared Sulfites in Yulanpian Brand Dried Slices of Tender Bamboo Shoots (September 26)

Lion Pavilion Issues Alert on Undeclared Sulfites in Yulanpian Brand Dried Slices of Tender Bamboo Shoots (September 26)
Thu, 02 Oct 2008 07:44:00 -0500

Yulanpian Brand Dried Slices of Tender Bamboo Shoots is sold in a 230gram, clear plastic package with the following code: 2008.1.3 and was distributed nationwide. It is a product of China.

Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 2 Oct 2008 10:04:07 -0500 (CDT)
Subject: FDA MedWatch- Medtronic Neuromodulation INDURA One-Piece Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit- Class I Recall

Medtronic and FDA notified healthcare professionals of the Class I Recall of several Medtronic intrathecal catheters and intrathecal catheter revision kits used with the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps that store and deliver parenteral drugs to the intrathecal space. The products were recalled because of potential misconnections of the Medtronic Sutureless Connector Catheters from the catheter port on the pump. These misconnections have resulted in a blockage between the sutureless pump connector and the catheter port on the pump and disconnection from the pump connector. See the FDA Recall Notice for recommendations for healthcare professionals.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Class I Recall Notice regarding the above issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#INDURA

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U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 08:27:29 -0500 (CDT)
Subject: FDA Warning Letters Update

You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 09:23:00 -0500 (CDT)
Subject: What's New at CBER Update

You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Approval Information: Tuberculin, Purified Protein Derivative (Aplisol)
Posted: 10/1/2008, Approval Date: 9/23/2008

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 11:35:28 -0500 (CDT)
Subject: The October 2008 MedSun Newsletter is now available...

Medical Product Safety Network

Highlighted articles include:

Cutting a Battery Pack Cable Can Start a Fire
Cutting a battery pack cable can cause short circuits. In turn, can cause the batteries to discharge rapidly and produce intense heat and flammable gases. This article provides recommendations to avoid the risks of sparks, fires, toxic fumes and explosions. The summary of a recent MedSun report on battery packs in the clinical environment is also available...

Reporting Tip: Reporting Problems with Reprocessed Single Use Devices to FDA
This reporting tip clarifies how health professionals can best report an adverse event with a reprocessed single use device to the FDA...

Interventional Fluoroscopy: Reducing Radiation Risks
Interventional fluoroscopy is an increasingly important and valuable tool for treating disease, but it is not without risk. That is why it is important for the health care community, manufacturers and regulators to work together to optimize patient radiation dose...

Misprogramming PCA Concentration Leads to Dosing Errors
ISMP has received a small but concerning number of reports of overdoses with patient controlled analgesia (PCA) due to pump programming errors. Although every aspect in the PCA process has the potential for an error, ISMP is especially concerned about errors related to programming the concentration of the narcotic...

Proper Positioning of Pharmacy Label on Hospira PCA Vials will Avoid Interference with Scanning
A recent overdose was associated with the way pharmacy applied labels after preparing fentanyl PCA doses using the pump's compatible empty sterile glass vials. This article provides safe practice recommendations to prevent these errors...

FDA Clears Test to Help Doctors Manage Heart Transplant Patients
A non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection has been cleared for marketing by the FDA...

FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures
The FDA has approved a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture...

FDA Approves DNA Test to Measure Hepatitis B Virus Levels

FDA has approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections...

ROC Curves: Uncovering the Pearls and Avoiding the Pitfalls

ROC (receiver operating characteristic) curves are helpful for selecting optimal cutoffs for a test and have become a common tool in medicine to determine the clinical accuracy of lab tests...

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 14:06:03 -0500 (CDT)
Subject: What's New at CBER Update

You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 10/1/2008

Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 15:39:35 -0500 (CDT)
Subject: The October 2008 FDA Patient Safety News is now available...

You can find more information about FDA Patient Safety News, and watch or download the video program on our web site (http://www.fda.gov/psn). Stories in the October 2008 edition include:

Warning on Tendon Injuries with Fluoroquinolone Antibiotics

Boxed warning and Medication Guide needed to draw attention to the risk of tendon rupture and tendinitis with fluoroquinolone drugs such as Cipro…

CT Scanning May Cause Malfunction of Electronic Medical Devices

X-rays emitted during CT exams could adversely affect insulin pumps, neurostimulators, pacemakers, defibrillators…

Update on Cardiopulmonary Reactions with Ultrasound Micro-bubble Contrast Agents

Contrast agents Definity and Optison are no longer contraindicated for patients with unstable cardiopulmonary status; however, these high risk patients should be closely monitored…

Avoiding Cardiotoxicity with Mitoxantrone

The importance of monitoring LVEF during and after treatment with mitoxantrone…

Serious Complications from Using Recombinant Bone Morphogenetic Protein in the Cervical Spine

The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated, and FDA has not approved it for this use…

Potentially Fatal Glucose Monitoring Errors with Icodextrin

Some point-of-care glucose meters use a type of test strip that can't distinguish between glucose and other sugars…

For more FDA Patient Safety News, visit http://www.fda.gov/psn . Please send any comments, questions or suggestions about the program to PSNews@fda.gov

You are receiving this message because you subscribed to the FDA Patient Safety News mailing list. If you would like to modify your subscription or no longer wish to receive these messages, please go to http://www.accessdata.fda.gov/psn/mailinglist.cfm

Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 15:52:02 -0500 (CDT)
Subject: Interstate Certified Shellfish Shippers Update October 2008

* * * Interstate Certified Shellfish Shippers List * * *

The monthly ICSSL update is now available for download at http://www.cfsan.fda.gov/~ear/shellfis.html.

October 2008 Update

Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 15:03:32 -0500 (CDT)
Subject: Enforcement Report for October 1, 2008

Enforcement Report for October 1, 2008
Wed, 01 Oct 2008 13:34:00 -0500

Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 15:21:13 -0500 (CDT)
Subject: FDA Information Update for Health Professionals - October 1, 2008

U.S. Food and Drug Administration

Office of Special Health Issues

5600 Fishers Lane, HF-12

Rockville, Maryland 20857

Dear Colleague,

As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety information, announcements, and upcoming meetings. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.

PRODUCT SAFETY INFORMATION:

FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of Lou Gehrig's Disease (September 29)

A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The analysis was reported on Monday, Sept. 29, 2008 in Pharmacoepidemiology and Drug Safety.

FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain (September 23)

FDA announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses.

Epoetin alfa - Early Communication about an Ongoing Safety Review (September 23)

FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke.

ANNOUNCEMENTS:

FDA Updates Health Information Advisory on Melamine Contamination (September 26)

FDA is alerting consumers that seven Mr. Brown instant coffee and milk tea products are being recalled by the Taiwanese company, King Car Food Industrial Co. Ltd., due to possible contamination with melamine.

FDA Releases its Fourth Issue of the FDA Drug Safety Newsletter (September 23)

This publication provides postmarketing information to healthcare professionals to enhance communication of new drug safety information, raise awareness of reported adverse events, and stimulate additional adverse event reporting.

The Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism (September 15)

Acting Surgeon General Steven K. Galson, M.D., M.P.H., issued a Call to Action to reduce the number of cases of deep vein thrombosis and pulmonary embolism in the United States.

UPCOMING MEETINGS:

Over the Counter Cough and Cold Medications for Pediatric Use

DATE AND TIME: October 2, 8:00 a.m.
LOCATION: Sheraton Washington North Hotel, 4095 Powder Mill Road, Beltsville, MD.
CONTACT: Faith Dugan, FDA, 301-796-3446.

FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance

DATE AND TIME: October 2-3, 2008, 8:00 a.m.
LOCATION: Hilton Wash. DC North/ Gaithersburg, 620 Perry Pkwy, Gaithersburg, MD 20877

CONTACT: Megan Moynahan, 240-276-8707.

Endocrinologic and Metabolic Drugs Advisory Committee

DATE AND TIME: October 21, 8:00 a.m.
LOCATION: Crowne Plaza Hotel, Washington DC-Silver Spring, 8777 Georgia Ave.,
Silver Spring, MD, (301) 589-0800
CONTACT: Paul Tran, R.Ph., 301-827-7001.

Peripheral and Central Nervous System Drugs Advisory Committee

DATE AND TIME: October 23, 8:00 a.m.
LOCATION: Hilton Washington DC, Silver Spring, The Ballrooms, 8727 Colesville Road,
Silver Spring, MD
CONTACT: Diem-Kieu Ngo, 301–827–7001

Joint Meeting of the Antiviral Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee

DATE AND TIME: October 29, 8:00 a.m.
LOCATION: Hilton The Ballrooms, 1750 Rockville Pike, Rockville, MD.
CONTACT: Paul Tran, Center for Drug Evaluation and Research, 301-827-6793.

Structured Product Labeling Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry

DATE AND TIME: November 17, 8:30 a.m.
LOCATION: Universities at Shady Grove, Multipurposes Room, Building II, 9630 Gudelsky Dr., Rockville, MD.
CONTACT: Donna Lipscomb, Center for Biologics Evaluation and Research, 301-827-2000.

For notice of advisory committee meetings posted on earlier Health Professional communications additional information can be found after the meeting has been held. For information such as presentations, transcripts and voting results, please see FDA's Advisory Committee page.

RESOURCES:

The FDA the Week: Andy's Take (September 26, 2008)

Commissioner for Food and Drugs Andrew von Eschenbach discusses weekly FDA issues of interest to the American consumer and occasionally preview upcoming FDA issues and events. Featured this week is "Nutrition: Your Prescription for Health."

If you have any questions, you may send an email to webmail@oc.fda.gov or contact us at the numbers listed below.

Sincerely,

Janelle Derbis, PharmD

Janelle.derbis@fda.hhs.gov

312-596-6516 (Chicago)

Brenda L. Evelyn, SBB(ASCP)

Brenda.evelyn@.fda.hhs.gov

301-827-4460

Heidi Marchand, PharmD

Heidi.marchand@fda.hhs.gov

301-827-4460

Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 16:03:15 -0500 (CDT)
Subject: Mr. Brown 3-In-1 and and 2-In-1 Powdered Packets in Bag Coffee Mixes Due To Health Risk (October 1)

Mr. Brown 3-In-1 and and 2-In-1 Powdered Packets in Bag Coffee Mixes Due To Health Risk (October 1)
Wed, 01 Oct 2008 16:01:00 -0500

The recall was initiated after the manufacturer notified Sunny Maid that these 3-in-1 and 2-in-1 Coffee Mix products may contain melamine. Although only certain lots are potentially contaminated, Sunny Maid is recalling all lots. No illnesses associated with this product have been reported to date.

Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 16:04:35 -0500 (CDT)
Subject: FDA MedWatch - The October 2008 FDA Patient Safety News Video is now available...

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.

Stories in the October 2008 edition include:

Warning on Tendon Injuries with Fluoroquinolone Antibiotics

Boxed warning and Medication Guide needed to draw attention to the risk of tendon rupture and tendinitis with fluoroquinolone drugs such as Cipro…

CT Scanning May Cause Malfunction of Electronic Medical Devices

X-rays emitted during CT exams could adversely affect insulin pumps, neurostimulators, pacemakers, defibrillators…

Update on Cardiopulmonary Reactions with Ultrasound Micro-bubble Contrast Agents

Contrast agents Definity and Optison are no longer contraindicated for patients with unstable cardiopulmonary status; however, these high risk patients should be closely monitored…

Avoiding Cardiotoxicity with Mitoxantrone

The importance of monitoring LVEF during and after treatment with mitoxantrone…

Serious Complications from Using Recombinant Bone Morphogenetic Protein in the Cervical Spine

The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated, and FDA has not approved it for this use…

Potentially Fatal Glucose Monitoring Errors with Icodextrin

Some point-of-care glucose meters use a type of test strip that can't distinguish between glucose and other sugars…

For more FDA Patient Safety News, visit http://www.fda.gov/psn . Please send any comments, questions or suggestions about the program to PSNews@fda.gov

Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 17:03:33 -0500 (CDT)
Subject: Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial)

Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial)
Fri, 26 Sep 2008 08:45:00 -0500

See Web site for additional information

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

Thursday, October 2, 2008

fU.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 30 Sep 2008 05:53:07 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page \| CDRH Home Page \| Search \| A-Z Index

Date: September 30, 2008

The following new items were added to the CDRH web pages on September 29, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Electronic Copies for Pre-Market Submissions (Updated 09/08)

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 30 Sep 2008 06:41:48 -0500 (CDT)
Subject: CDER New 9/29/2008

September 29, 2008

Drug Development and Drug Interactions: Meetings: FDA Critical Path Transporter Workshop - (updated)
Public Hearing for Over-the-Counter Cough and Cold Medications, October 2, 2008, Beltsville, Maryland: Meeting information and registration - (updated)

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 30 Sep 2008 09:26:06 -0500 (CDT)
Subject: What's New at CBER Update

You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Vacancy Announcement - Health Scientist (HS)/Lead/Supv HS
Posted: 9/30/2008

Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 30 Sep 2008 11:03:42 -0500 (CDT)
Subject: Keeping Watch Over Direct-to-Consumer Ads

Keeping Watch Over Direct-to-Consumer Ads
Tue, 30 Sep 2008 10:11:00 -0500

FDA regulates direct-to-consumer advertising for prescription drugs, working to ensure that ads are truthful, balanced, and accurate.

Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 30 Sep 2008 13:13:13 -0500 (CDT)
Subject: CDER's Small Business Assistance Bulletin

Small Business Assistance (SBA) in the Center for Drug Evaluation and Research (CDER) provides assistance to businesses with less than 500 employees in the development of new pharmaceutical products. Through an extensive outreach program SBA provides guidance and information to small pharmaceutical businesses through its ListServ, Q&A's, workshops, and website. The ListServ provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical businesses which includes Federal Register notices, guidances, workshop announcements

1. Structured Product Labeling (SPL) Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry Workshop. The purpose of the public workshop is to provide the biologics industry with guidance on submitting to FDA content of labeling in SPL format, present an overview of FDA's voluntary pilot program for electronic submission of drug establishment registration and drug listing information under the regulations, and exhibit vendor SPL authoring tools that may be used in the creation and manipulation of SPL content of labeling. The public workshop will be held on November 17, 2008, from 8:30 a.m. to 4 p.m. The location will be held at the Universities at Shady Grove, Multipurpose Room, Building II, 9630 Gudelsky Dr., Rockville, MD 20850. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-21968.pdf and http://www.fda.gov/CBER/meetings/spl111708.htm

2. FDA Critical Path Transporter Workshop. The Workshop is co-sponsored by DIA and FDA in collaboration with PhRMA, American Association of Pharmaceutical Scientists, and International Society for the Study of Xenobiotics. Leading scientists from academia, the FDA and industry will present and lead discussion on the current status of the rapidly emerging field of drug transporters, the clinical relevance of drug uptake and efflux transporters, and the application of in vitro and in vivo tools to drug discovery and development. Participants will be encouraged to join discussions on best practices and future directions. The workshop will culminate in the generation of a White Paper. The Workshop will be from Oct 2 2008 8:00 AM - Oct 3 2008 5:00 PM. Location will be in Bethesda, Md. http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=17183&eventType=Meeting

3. New Guidance. End-of-Phase 2A Meetings. The Food and Drug Administration announced in a Federal Register notice of September 26, 2008, the availability of this draft guidance for industry. This draft guidance provides information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs) who seek guidance on employing clinical trial simulation and quantitative modeling of prior knowledge (e.g., drug, disease, placebo) to design trials for better dose response estimation, dose selection, and other appropriate issues. This draft guidance is intended to further FDA initiatives directed at identifying opportunities to facilitate the development of innovative medical products and to improve the quality of drug applications through early meetings with sponsors. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-22669.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0514-gdl.pdf

4. Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs. The Food and Drug Administration announced in a Federal Register notice of September 29, 2008, that the agency is amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report. We are taking this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly. We are using direct final rulemaking for this action because the agency expects that there will be no significant adverse comment on the rule. In the proposed rule section of this issue of the Federal Register, we are concurrently proposing and soliciting comments on this rule. If significant adverse comments are received, we will withdraw this final rule and address the comments in a subsequent final rule. FDA will not provide additional opportunity for comment. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-22833.pdf

5. Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs; Companion Document to Direct Final Rule. The Food and Drug Administration announced in a Federal Register notice of September 29, 2008, that the agency is publishing a companion proposed rule to the direct final rule cited above which is intended to amend our regulations to require that the holder of a new drug application (NDA) submit certain information in an annual report regarding authorized generic drugs. The agency is taking this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-22829.pdf

6. A New CDER Website: FDA Listing of Authorized Generics as of September 26, 2008. http://www.fda.gov/cder/ogd/AG_Listing.htm

7. A New Guidance for Industry: Individual Product Bioequivalence Recommendations. 19 Newly added Bioequivalents. http://www.fda.gov/cder/guidance/bioequivalence/default.htm

8. Warning Letters and Untitled Letters to Pharmaceutical Companies during 2008 by FDA. http://www.fda.gov/cder/warn/warn2008.htm

9. The Small Business Advocate. The Small Business Advocate is a newsletter published by the Office of Advocacy at the Small Business Administration. The recent newsletter is attached. http://www.sba.gov/advo/aug_sep08.pdf

Ron Wilson Director of Small Business Assistance wilsonr@cder.fda.gov

Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 30 Sep 2008 15:11:51 -0500 (CDT)
Subject: CDER New 9/30/2008

September 30, 2008

New and Generic Drug Approvals
- Adagen (pegademase bovine) Injection, Enzon Pharmaceuticals, Inc., Labeling Revision
- Alfuzosin Hydrochloride Extended-Release Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
- Alprazolam Tablets, Vintage Pharmaceuticals, LLC, Approval
- Capoten (captopril) Tablets, Par Pharmaceutical, Inc., Labeling Revision
- Exubera (insulin [rDNA origin]) Inhalation Powder, Pfizer Inc., Labeling Revision
- Hydroxyzine Hydrochloride Tablets, Amneal Pharmaceuticals, Approval
- Moexipril Hydrochloride and Hydrochlorothiazide Tablets, Paddock Laboratories, Inc., Approval
- Tamiflu (oseltamivir phosphate) Capsules, Hoffmann-La Roche, Inc., Labeling Revision
- Vaseretic (enalapril maleate and hydrochlorothiazide) Tablets, Biovail Laboratories International SRL, Labeling Revision
- Vasotec (enalapril maleate) Tablets, Biovail Laboratories International SRL, Labeling Revision

Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 30 Sep 2008 18:02:51 -0500 (CDT)
Subject: FDA Awards $5.2 Million in Grants to Further Food and Feed Safety

FDA Awards $5.2 Million in Grants to Further Food and Feed Safety
Tue, 30 Sep 2008 17:11:00 -0500

The U.S. Food and Drug Administration today announced the awarding of 17 grants to enhance food and feed safety. These grants fund major cooperative agreements in four major areas. The FDA awarded a combined $5.2 million in these one-year grants to various state and local regulatory agencies.

Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 30 Sep 2008 10:43:41 -0500 (CDT)
Subject: FDA MedWatch - Statin drugs and risk of amyotrophic lateral sclerosis (ALS)

Statin drugs and amyotrophic lateral sclerosis (ALS)
Audience: Neurologists, cardiologists, consumers
An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The FDA analysis, undertaken after the agency received a higher than expected number of reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.

Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA New Release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Statin

Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 30 Sep 2008 11:03:41 -0500 (CDT)
Subject: Is It Really FDA Approved?

Is It Really FDA Approved?
Tue, 30 Sep 2008 10:11:00 -0500

Some marketers say their products are "FDA approved", but how can you know for sure?

Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 30 Sep 2008 12:03:38 -0500 (CDT)
Subject: NY Fish Inc. Recalls Imperial-European Style Smoked Salmon Because of Possible Health Risk (September 26)

NY Fish Inc. Recalls Imperial-European Style Smoked Salmon Because of Possible Health Risk (September 26)
Tue, 30 Sep 2008 11:21:00 -0500

NY FISH INC. of Brooklyn, NY, is recalling I [heart symbol] NY FISH brand IMPERIAL-EUROPEAN STYLE SMOKED SALMON, vacuum packed, in 3 oz., 8 oz., 16 oz., and whole sides ("to be weighed at time of sale") sizes with lot numbers 513 1340, 514 1340, 515 1340, and 516 1340, because they have the potential to be contaminated with Listeria monocytogenes.

Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 30 Sep 2008 18:02:50 -0500 (CDT)
Subject: FDA Awards up to $2.5 Billion to Modernize Information Technology over Ten Years

FDA Awards up to $2.5 Billion to Modernize Information Technology over Ten Years
Tue, 30 Sep 2008 17:11:00 -0500

The U.S. Food and Drug Administration today announced the selection of ten contractors to receive up to a total of $2.5 billion for information technology (IT) and data center management services over the next ten years.

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 29 Sep 2008 07:18:15 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page \| CDRH Home Page \| Search \| A-Z Index

Date: September 29, 2008

The following new items were added to the CDRH web pages on September 26, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
	Summary Information for: NexGen® LPS-Flex Mobile Bearing and LPS-Mobile Bearing Knees

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 29 Sep 2008 13:03:37 -0500 (CDT)
Subject: Addressing Questions About Gardasil

Addressing Questions About Gardasil
Mon, 29 Sep 2008 12:24:00 -0500

FDA addresses the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV)

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 29 Sep 2008 16:03:21 -0500 (CDT)
Subject: FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of Lou Gehrig's Disease

FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of Lou Gehrig's Disease
Mon, 29 Sep 2008 15:16:00 -0500

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1

From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 15:05:50 -0500 (CDT)
Subject: What's New at CBER Update

You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

PDUFA - User Fee Billable Products Approved Under Section 351 of the PHS Act - Updated
Posted: 9/26/2008

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 15:07:30 -0500 (CDT)
Subject: CDER New 9/22 - 26/2008

September 26, 2008

Guidance for Industry: Individual Product Bioequivalence Recommendations 19 Newly added Bioequivalents.
Drugs Shortages: Drugs to be Discontinued: SecreFlo (porcine secretin for injection, 16 mcg/vial)
Drugs Shortages: Resolved Drugs Shortages: Zanosar (Streptozocin) 1gm/vial Injection
FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. MedWatch Safety Information
New and Generic Drug Approvals
- Betamethasone Dipropionate Topical Cream, Glenmark Generics, Approval
- Didanosine Delayed-Release Capsules, Aurobindo Pharma, Approval
- Heparin Sodium Injection, APP Pharmaceuticals, LLC, Labeling Revision
- Lariam (mefloquine hydrochloride) Tablets, Hoffmann-La Roche, Labeling Revision
- Nabumetone Tablets, Dr. Reddy's Laboratories, Ltd., Approval
- Noroxin (norfloxacin) Tablets, Merck & Co. Inc., Labeling Revision
- Symmetrel (amantadine hydrochloride) Syrup, Endo Pharmaceuticals, Labeling Revision
- Symmetrel (amantadine hydrochloride) Tablets, Endo Pharmaceuticals, Labeling Revision
Office of Generic Drugs: List of Authorized Generic Drugs (updated)
Warning and Untitled Letters
- Adderall XR Capsules (Warning Letter)
- Concerta (methylphenidate HCl)
- Diovan (valsartan) Tablets
- Focalin XR (dexmethylphenidate)
- Methylin (methylphenidate HCl)
- Strattera (atomoxetine HCl) (Warning Letter)

September 25, 2008

FDA orders companies to stop marketing unapproved drug products that contain papain in a topical dosage form. Questions and Answers (updated)
Guidance for Industry: End-of-Phase 2A Meetings [PDF] or [HTML]
International Conference on Harmonization (ICH) Public Meeting, October 21, 2008, Rockville, Maryland: Meeting information and registration - (updated)
New and Generic Drug Approvals
- Amlodipine Besylate Tablets, Torrent Pharmaceuticals, Ltd., Approval
- Carboplatin I.V. Injection, Sun Pharmaceutical Industries, Ltd., Approval
- Nasacort AQ (triamcinolone acetonide) Nasal Spray, Sanofi-Aventis US, LLC, Patient Population Altered
- RETROVIR (zidovudine) Capsules, GlaxoSmithKline, New Dosage Regimen
- RETROVIR (zidovudine) Syrup, GlaxoSmithKline, New Dosage Regimen
- RETROVIR (zidovudine) Tablets, GlaxoSmithKline, New Dosage Regimen
- Tarceva (erlotinib hydrochloride) Tablets, OSI Pharmaceuticals, Inc., New Dosage Regimen
- Technetium Tc 99m Sestamibi (technettium tc-99m sestamibi kit) Injection, Mallinckrodt Inc., Approval
- Ventavis (iloprost) Inhalation Solution, Actelion, Ltd., Labeling Revision

September 24, 2008

September 23, 2008

New and Generic Drug Approvals
- AdreView (iobenguane I-123) Injection, GE Healthcare, Approval
- Uroxatral (alfuzosin hydrochloride) Extended-Release Tablets, Sanofi-Aventis US, LLC, Labeling Revision
- Veregen (sinecatechins) Ointment, MediGene, Inc., Labeling Revision
Paragraph IV Patent Certifications (updated)

September 22, 2008

FDA orders companies to stop marketing unapproved drug products that contain papain in a topical dosage form. Questions and Answers
FDA orders companies to stop marketing unapproved ophthalmic balanced salt solutions (BSS). Questions and Answers

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 16:02:55 -0500 (CDT)
Subject: Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection

Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection
Fri, 26 Sep 2008 14:40:00 -0500

See Web site for additional information

Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 18:26:04 -0500 (CDT)
Subject: The FDA this Week: Andy's Take -- Nutrition: Your Prescription for Health

The FDA this Week: Andy's Take -- Nutrition: Your Prescription for Health
Fri, 26 Sep 2008 21:09:00 -0500

We as patients often assume that a prescription for health involves taking medicines. The drugs that FDA approves are essential for treating disease, but perhaps the most important prescription to prevent many diseases is the food we eat.

My Take is that our food not only needs to be safe to protect our health – but also nutritious, in order to promote our health.

Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 10:20:59 -0500 (CDT)
Subject: FDA MedWatch - Epoetin alfa- Preliminary Safety Findings Show More Deaths In Patients Given Epoetin-alpha Versus Placebo

FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. The clinical trial utilized doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product. Over a period of ninety days after the start of the trial, there were more deaths in the group of patients who received epoetin alfa compared to patients who received the placebo (16% versus 9%). Roughly half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring among approximately 4% of patients who received epoetin alfa compared to 1% of patients in the placebo group.

FDA anticipates the receipt of additional data within the next several weeks. As soon as the review of these data is complete, FDA will communicate our conclusions and recommendations to the public. The finding of increased mortality in patients receiving epoetin alfa in the German trial suggests the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA's Early Communication About An Ongoing Safety Review regarding this issue.

http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA3

Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 11:03:00 -0500 (CDT)
Subject: FDA Updates Health Information Advisory on Melamine Contamination

FDA Updates Health Information Advisory on Melamine Contamination
Fri, 26 Sep 2008 10:28:00 -0500

The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine.

Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 14:02:42 -0500 (CDT)
Subject: Vaccines Stand Ready for Flu Season

Vaccines Stand Ready for Flu Season
Fri, 26 Sep 2008 13:30:00 -0500

FDA has approved six vaccines for the 2008-2009 flu season.

Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 16:02:54 -0500 (CDT)
Subject: Updated: Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers. Full Version.

Updated: Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers. Full Version.
Fri, 26 Sep 2008 14:20:00 -0500

As part of a multi-year phase out, chlorofluorocarbon (CFC) propelled albuterol inhalers will not be available after December 31, 2008. Healthcare professionals should transition patients to the hydrofluoralkane (HFA) propelled albuterol inhalers now. Full Version.

Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 16:02:54 -0500 (CDT)
Subject: Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial)

Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial)
Fri, 26 Sep 2008 08:45:00 -0500

See Web site for additional information

Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 26 Sep 2008 20:02:54 -0500 (CDT)
Subject: QFCO, Inc. Recalls White Rabbit Candy Because of Possible Health Risk (September 26)

QFCO, Inc. Recalls White Rabbit Candy Because of Possible Health Risk (September 26)
Fri, 26 Sep 2008 18:58:00 -0500

QFCO, Inc. of Burlingame, California is recalling White Rabbit Candy because it may be contaminated with Melamine. Product was distributed to the states of CA, GA, HI, IL, MN, NY, OR, TX, WA through wholesale distributors to retail stores.

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U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 25 Sep 2008 08:02:49 -0500 (CDT)
Subject: What's New at CBER Update

You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Vacancy Announcement - Supervisory Regulatory Counsel, ADPRP/OCD
Posted: 9/25/2008

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 25 Sep 2008 08:06:33 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page \| CDRH Home Page \| Search \| A-Z Index

Date: September 25, 2008

The following new items were added to the CDRH web pages on September 24, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: Food and Drug Administration Medical Products Reporting Program
	FDA Public Health Notification: Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 25 Sep 2008 10:04:33 -0500 (CDT)
Subject: What's New at CBER Update

You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Information About Heparin and Plasma Derived Products
Posted: 9/25/2008

Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 25 Sep 2008 14:29:11 -0500 (CDT)
Subject: eMDR (Electronic Medical Device Reporting) Update -- Test System down this weekend

You are subscribed to eMDR (Electronic Medical Device Reporting) for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Please note that eMDR Test System will be down Friday, September 26, 2008 starting at 9am EST. The test system will be back up Monday, September 29, 2008, 7am EST. The eMDR Production System will not be affected.

Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 25 Sep 2008 07:03:56 -0500 (CDT)
Subject: CaJohns Fiery Foods Company Recalls HDH Grillin' Sauce (September 24)

CaJohns Fiery Foods Company Recalls HDH Grillin' Sauce (September 24)
Thu, 25 Sep 2008 06:28:00 -0500

CaJohns Fiery Foods Company is recalling a total of 103 individual bottles of HDH Grillin' Sauce sold between the dates of 01/01/07 and 09/15/08. This recall is initiated due to the possibility of non-declared contents on the Ingredient Declaration. The products contain the listed Worcestershire Sauce, but may not be parenthetically listed as to it's ingredients one of which is Anchovies, a serious allergen to specific individuals. These products also contain the listed Soy Sauce, but may not be parenthetically listed as to it's ingredients. Soy Sauce contains Soybeans and Wheat which are serious allergens to specific individuals.

Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 25 Sep 2008 11:28:54 -0500 (CDT)
Subject: Enforcement Report for September 24, 2008

Enforcement Report for September 24, 2008
Thu, 25 Sep 2008 09:48:00 -0500

Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 24 Sep 2008 07:02:50 -0500 (CDT)
Subject: Mom's Food Products, Inc. Issues Allergy Alert On Undeclared Eggs in Sandwiches and Potato Salad (September 23)

Mom's Food Products, Inc. Issues Allergy Alert On Undeclared Eggs in Sandwiches and Potato Salad (September 23)
Wed, 24 Sep 2008 06:30:00 -0500

Mom's Food Products, Inc. of Ft Worth, TX is recalling all Tuna Salad sandwiches, Pimento Cheese sandwiches, and potato salad because they may contain eggs in the salad dressing. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 24 Sep 2008 09:07:45 -0500 (CDT)
Subject: What's New at CBER Update

You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

SOPP 8416: CBER Initiated Second Level STNs
Posted: 9/23/2008

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 24 Sep 2008 09:37:30 -0500 (CDT)
Subject: FDA Warning Letters Update

You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 24 Sep 2008 11:03:49 -0500 (CDT)
Subject: Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated

Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated
Wed, 24 Sep 2008 10:25:00 -0500

See additional information in Related Information section.

Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 24 Sep 2008 12:50:12 -0500 (CDT)
Subject: Public Health Notifications Update

You are subscribed to Public Health Notifications for U.S. Food & Drug Administration (FDA), Center for Devices and Radiological Health.

The FDA has posted a new Public Health Notification regarding Radiofrequency Ablation of Lung Tumors. This Notification is intended to inform you of the regulatory status of RF ablation devices used to treat lung tumors, the regulatory basis for FDA's clearance of these devices for the indication of general soft tissue ablation, and the public health concerns related to the specifici use of RF ablation to treat lung tumors. This Notification is available by clicking here.

Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 24 Sep 2008 13:58:13 -0500 (CDT)
Subject: What's New at CBER Update

You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 9/24/2008

Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 24 Sep 2008 07:02:47 -0500 (CDT)
Subject: Fineland Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Pumpkin Seeds (September 23)

Fineland Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Pumpkin Seeds (September 23)
Wed, 24 Sep 2008 06:30:00 -0500

Ying Feng Foodstuffs Brand Pumpkin Seeds is sold in a 10 ounce, clear plastic package with the following code: EXP 03 25 2010 and was distributed nationwide. It is a product of China.

Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 24 Sep 2008 11:03:48 -0500 (CDT)
Subject: Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated

Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated
Wed, 24 Sep 2008 10:25:00 -0500

See information in Related Information section.

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U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 23 Sep 2008 07:54:09 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page \| CDRH Home Page \| Search \| A-Z Index

Date: September 23, 2008

The following new items were added to the CDRH web pages on September 22, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]
	PMA Final Decisions for August 2008

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 23 Sep 2008 09:08:15 -0500 (CDT)
Subject: What's New at CBER Update

You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

SOPP 8116: Using Electronic Signatures for Investigational and Marketing Regulatory Document Concurrence/Signoff
Posted: 9/23/2008

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 23 Sep 2008 11:03:25 -0500 (CDT)
Subject: FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain

FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain
Tue, 23 Sep 2008 10:30:00 -0500

The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses.

Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 23 Sep 2008 13:57:35 -0500 (CDT)
Subject: FDA MedWatch - Tarceva (erlotinib) - Cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva

Tarceva (erlotinib) Tablets
Audience: Oncological healthcare professionals
OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Patients with hepatic impairment receiving Tarceva should be closely monitored during therapy and the product should be used with extra caution in patients with total bilirubin >3x ULN. Dosing should be interrupted or discontinued if changes in liver function are severe, such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside the normal range. New information from a pharmacokinetic study in patients with moderate hepatic impairment associated with significant liver tumor burden has been provided in the revised prescribing information, and other recommendations are included in the WARNINGS and DOSAGE AND ADMINISTRATION sections.

Read the entire 2008 MedWatch Safety Summary, including links to the manufacturer's Dear Healthcare Provider Letter and the revised prescribing information for Tarceva, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tarceva.

Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 23 Sep 2008 14:09:15 -0500 (CDT)
Subject: FDA MedWatch - Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% - Particulate matter detected in product

Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10%
Audience: Hospital ER and ICU medical and nursing personnel, risk managers
Ucyclyd Pharma, Inc. informed healthcare professionals of the detection of particulate matter in the Ammonul Injection product. This particulate matter may impact the safe use of Ammonul. To ensure optimal patient care, healthcare providers are being instructed to use a MilIex Durapore GV 33 mm Sterile Syringe Filter (0.22 µm ) during the admixture process when injecting Ammonul into the 10% Dextrose IV bag. Since this particulate matter may not be readily seen on visual inspection, a filter must be employed in all cases regardless of whether particulate matter is seen in the vial. Testing has confirmed the removal of this specific particulate when using this filter to admix Ammonul. Contact Ucyclyd Pharma, 1-888-829-2593, or 1-800-900-6389 -- a representative is available 24 hours, seven days a week.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Provider Letter, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Ammonul.

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FDA News

Tuesday, October 14, 2008

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Announcing Availability of the new Employees FIRST Food Defense Awareness Training Kit for First-Line Employees

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

MedWatch - Tiotropium (Spiriva): updated information on risk of stroke and reports of cardiovascular adverse outcomes

Monday, October 13, 2008

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of Lou Gehrig's Disease (September 29)

FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain (September 23)

FDA Updates Health Information Advisory on Melamine Contamination (September 26)

The Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism (September 15)

Over the Counter Cough and Cold Medications for Pediatric Use

Endocrinologic and Metabolic Drugs Advisory Committee

Peripheral and Central Nervous System Drugs Advisory Committee

Joint Meeting of the Antiviral Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee

Structured Product Labeling Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry

Thursday, October 2, 2008

fU.S. Food & Drug Administration (FDA) Daily Digest Bulletin

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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