Wednesday, September 24, 2008

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

UpDate : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 22 Sep 2008 07:48:25 -0500 (CDT)
Subject: CDRH New Update

Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
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CDRHNEW Logo Date: September 22, 2008

The following new items were added to the CDRH web pages on September 19, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

* Summary Information for: Akreos™ Posterior Chamber Intraocular Lens PDF
* Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence; Availability Text PDF

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UpDate : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 22 Sep 2008 16:53:28 -0500 (CDT)
Subject: FDA Data Standards Update - Biologics Industry SPL Public Workshop - Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry

 

 

 

Greetings,

The FDA Data Standards Council's SPL webpage was updated to include a link to the Federal Register notice which announced the "Structured Product Labeling Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry; Public Workshop."

The link to this announcement is located on this web page http://www.fda.gov/oc/datacouncil/spl.html  under the heading "Resources."

 

Lonnie Smith

Project Manager

FDA Data Standards Council

 

.

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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: Sat, 20 Sep 2008 10:02:26 -0500 (CDT)
Subject: FDA Updates Health Information Advisory on Melamine Contamination

FDA Updates Health Information Advisory on Melamine Contamination
Sat, 20 Sep 2008 09:09:00 -0500

On September 12, 2008, in light of reports from China of melamine contaminated infant formula, the FDA issued a Health Information Advisory to proactively reassure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Chinese communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants. The FDA had contacted the companies who manufacture infant formula for distribution in the United States and received information from the companies that they are not importing formula or source materials from China.

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Saturday, September 20, 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, 19 Sep 2008 06:51:25 -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.

Supplement Approval: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil) - Statistical
Review and Evaluation
Posted: 9/18/2008

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 07:57:12 -0500 (CDT)
Subject: CDER New 9/18/2008

FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

CDERnew Logo

September 18, 2008

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 08:07:42 -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: FDA Regulations; Technical Amendment; Final Rule; Correction - 9/19/2008

Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 08:20:49 -0500 (CDT)
Subject: CDRH New Update

Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
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CDRHNEW Logo Date: September 19, 2008

The following new items were added to the CDRH web pages on September 18, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

* Draft Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence Text PDF
* Maturity Health Matters: FDA Health News for Older Adults and Their Caregivers (Fall 2008 Issue) Text

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Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 10:05:13 -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.

FEDERAL REGISTER: FDA Regulations; Technical Amendment; Final Rule; Correction - 9/19/2008

Public Workshop: Structured Product Labeling Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry
Posted: 9/19/2008

Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 11:06:51 -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 - Biologist/Lead/Supv Biologist
Posted: 9/19/2008

Vacancy Announcement - Microbiologist /Lead /Supv Microbiologist
Posted: 9/19/2008

Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 14:23:45 -0500 (CDT)
Subject: CDER New 7/19/2008

FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

CDERnew Logo

September 19, 2008

Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 19:43:46 -0500 (CDT)
Subject: The FDA this Week: Andy's Take -- FDA: Listening and Leading: How We Promote and Protect Your Health

The FDA this Week: Andy's Take -- FDA: Listening and Leading: How We Promote and Protect Your Health
Fri, 19 Sep 2008 20:52:00 -0500

Welcome to Andy's Take. I'm Susan Winckler, FDA's Chief of Staff, and I am pleased to bring you this week's edition. In a typical week, you may hear many news reports that mention the FDA. Those reports provide a brief snapshot of FDA work on your behalf.

My Take is that depending on your interest, you may only have seen one of those many snapshots this week—or many reports about just one topic. And those reports might not have explained where FDA was in our decision-making process. Here's a recap of some of our work this week, where we were listening, clarifying, leading, educating, and taking action, as we assess the science about the food and medical products you use on a daily basis.

 

Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 14:02:37 -0500 (CDT)
Subject: Derringer Foodservices Issues Allergy Alert on Albacore Tuna Salad Hoagie (September 17)

Derringer Foodservices Issues Allergy Alert on Albacore Tuna Salad Hoagie (September 17)
Fri, 19 Sep 2008 13:31:00 -0500

This product is being recalled due to the omission of egg in the ingredient statement following the ingredient Reduced Calorie Mayonnaise. The recall decision was based on a potential allergen was included in the product and excluded from the label ingredient statement. This label omission was discovered in a standard ingredient statement audit.


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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, 18 Sep 2008 06:33:11 -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: Thu, 18 Sep 2008 07:53:50 -0500 (CDT)
Subject: CDRH New Update

Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
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CDRHNEW Logo Date: September 18, 2008

The following new items were added to the CDRH web pages on September 17, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

* Federal Register: Medical Devices; Medical Device Reporting; Baseline Reports; Confirmation of Effective Date Text PDF

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Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 08:37:29 -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 - Consumer Safety Officer (CSO)/Lead /Supv CSO
Posted: 9/18/2008

Vacancy Announcement - Consumer Safety Officer (CSO)/Lead /Supv CSO
Posted: 9/18/2008

Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 10:09:15 -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.

PDA/FDA Joint Meeting - Slide Presentations
Posted: 9/18/2008

Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 11:06:19 -0500 (CDT)
Subject: Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10%

FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10%
Thu, 18 Sep 2008 09:10:00 -0500

See information in Related Information section.

Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 13:34:30 -0500 (CDT)
Subject: Drug Safety Newsletter Update

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

Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 15:08:26 -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.

"Mammography Equipment Evaluation (MEE) Scope for Newly Installed FFDM Systems"

Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 15:10:07 -0500 (CDT)
Subject: FDA MedWatch- FDA Drug Safety Newsletter- Summer 2008 Edition Available For Healthcare Professionals And The Medical Community

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The Drug Safety Newsletter is a FDA publication for healthcare professionals and the medical community. The newsletter provides information on the findings of selected postmarketing drug safety reviews from FDA's Center for Drug Evaluation and Research. The newsletter also provides information on important emerging drug safety issues and recently approved new molecular entities. FDA hopes the newsletter will raise awareness of reported adverse events, and stimulate additional adverse event reporting by healthcare professionals.

Postmarketing Reviews:

Mefloquine Hydrochloride: Reports of Pneumonitis

Lenalidomide: Serious Skin Reactions

Amiodarone-Simvastatin Interaction: Reports of rhabdomyolysis

Icodextrin Portable Blood Glucose Monitor Test Strip Interaction: Reports of iatrogenic, sometimes fatal, hypoglycemia

Publication of this newsletter fulfills a commitment FDA made in its January 2007 response to the Institute of Medicine's (IOM) 2006 Report on The Future of Drug Safety - Promoting and Protecting the Health of the Public.

Read the entire MedWatch 2008 Safety Summary, including a link to the FDA Drug Safety Newsletter at:

http://www.fda.gov/cder/dsn/2008_summer/toc.htm

Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 15:48:34 -0500 (CDT)
Subject: New Issue of Maturity Health Matters Now Available!

The Fall 2008 edition of Maturity Health Matters is now available online. 

 

Recent major hurricanes make the first article, "Preparing for Natural Disasters" very important to our readers.  The next two articles contain information on "Injectable Cosmetic Wrinkle Fillers" and "Vaccines – Staying Healthy." 

 

We have published information on FDA's MedWatch in two previous issues, but because we believe that consumers and patients play such an important role in public health by reporting problems they have with products that FDA regulates, we have provided more information on MedWatch. 

 

The new issue is now available at http://www.fda.gov/cdrh/maturityhealthmatters.

 

Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 09:02:24 -0500 (CDT)
Subject: FDA Issues Draft Guidance on Regulating Genetically Engineered Animals

FDA Issues Draft Guidance on Regulating Genetically Engineered Animals
Thu, 18 Sep 2008 09:00:00 -0500

The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.

Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 11:06:15 -0500 (CDT)
Subject: Enforcement Report for September 17, 2008

Enforcement Report for September 17, 2008
Thu, 18 Sep 2008 08:28:00 -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 : 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 11:06:17 -0500 (CDT)
Subject: Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection)

FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection)
Thu, 18 Sep 2008 09:10:00 -0500

See Web site for additional information.

Update : 13
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 11:06:18 -0500 (CDT)
Subject: FDA Proposes Label Requirements for Refused Imported Foods

FDA Proposes Label Requirements for Refused Imported Foods
Thu, 18 Sep 2008 10:17:00 -0500

The U.S. Food and Drug Administration today issued a proposed rule designed to reduce a practice known as "port shopping" which puts the safety of imported food at risk.

Update : 14
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 11:06:22 -0500 (CDT)
Subject: Draft Guidance on Genetically Engineered Animals

Draft Guidance on Genetically Engineered Animals
Thu, 18 Sep 2008 10:00:00 -0500

The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals.

Update : 15
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 13:13:33 -0500 (CDT)
Subject: FDA MedWatch - Phosphocol P 32- Risk Of Leukemia Associated With Off-Label Intra-articular Use In Children

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Covidien and Mallinckrodt Inc. informed healthcare professionals of important new safety information in prescribing Phosphocol P 32. Phosphocol P 32 is approved for the intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease. Phosphocol P 32 may increase the risk for leukemia in certain situations. Two children (ages 9 and 14) with hemophilia developed acute lymphocytic leukemia approximately 10 months after intra-articular injections of Phosphocol P 32 (0.6 and 1.5 mCi total dose). This drug is not indicated in the intra-articular treatment of hemarthroses. Additionally, post marketing experience identified radiation injury (necrosis and fibrosis) to the small bowel, cecum, and bladder following administration of P 32 into the peritoneal cavity. Healthcare professionals should refer to the product's revised prescribing information for updated information regarding the appropriate use of Phosphocol P 32.

Read the entire 2008 MedWatch Safety Summaries, including a link to the manufacturer's Dear Healthcare Provider Letter and the revised prescribing information for Phosphocol P 32. 


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

Update : 16
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 18:02:45 -0500 (CDT)
Subject: K-Fat Inc. Issues Alert On Undeclared Sulfites In "Mut Gung Sweetened Ginger" (September 18)

K-Fat Inc. Issues Alert On Undeclared Sulfites In "Mut Gung Sweetened Ginger" (September 18)
Thu, 18 Sep 2008 17:09:00 -0500

K-FAT INC. of 13 Meadow St., Brooklyn, NY 11206, is recalling its 150g packages of MUT GUNG SWEETENED GINGER because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious life-threatening allergic reactions if they consume this product.

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


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