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
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | 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
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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
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
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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)
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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.
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