FDA News Digest for November 7, 2005

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

Title: Message

FDA News Digest

November 7, 2005

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IN THIS WEEK'S ISSUE

 

--  Access to Drug Information Easier With Electronic Drug Labels

--  Drug Approved to Treat Rare Leukemia and Lymphoma

--  FDA/Industry Project Aims to Predict Liver Toxicity in Drug Trials

--  Generic Version of Pediatric Drug Tentatively OK'd for AIDS Relief

--  FDA's Woodcock Honored for Advancing Medical Science

--  Recalls/Safety Alerts

--  Congressional Testimony

--  Upcoming Public Meetings

--  Question of the Week

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Access to Drug Information Easier With Electronic Drug Labels

 

FDA now requires drug makers to submit prescription drug label information in a new electronic format, which will allow doctors and consumers to easily access the product information found in drug package inserts. FDA hopes the improved access will result in fewer prescribing errors and better-informed decisions regarding prescription drugs. The electronic labels are a key element of DailyMed, an interagency online clearinghouse containing up-to-date information about current medicines. 

--  Press release: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01252.html

--  DailyMed Web site: http://dailymed.nlm.nih.gov

 

Drug Approved to Treat Rare Leukemia and Lymphoma

 

FDA has approved Arranon, a drug for treating children and adults with T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL), both classified as rare, or "orphan" diseases. Arranon, intended for patients whose disease has relapsed or not responded to at least two chemotherapy regimens, kills cancer cells by blocking the cell's ability to reproduce. FDA approved the drug under its accelerated approval and orphan products programs.

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01251.html

 

FDA/Industry Project Aims to Predict Liver Toxicity in Drug Trials

 

FDA has joined with Massachusetts-based BG Medicine to tackle the problem of predicting liver toxicity early in the drug development process. Liver toxicity is a major obstacle to efficient development of safe drugs. The project aims to identify liver toxicity "biomarkers" at the start of drug development to improve on current methods that recognize safety problems such as liver toxicity only after extensive clinical studies.

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01253.html

 

Generic Version of Pediatric Drug Tentatively OK'd for AIDS Relief

 

FDA has tentatively approved Lamivudine, the first generic version of the approved drug Epivir, for patients aged three months to 16 years. The agency's tentative approval means that though existing patents or exclusivity agreements prevent U.S. marketing of the product, the drug meets FDA's standards for quality, safety, and effectiveness. Lamivudine will now be available for use outside the United States under the President's Emergency Plan for AIDS Relief.

http://www.fda.gov/bbs/topics/news/2005/NEW01256.html

 

FDA's Woodcock Honored for Advancing Medical Science

 

FDA Deputy Commissioner for Operations Janet Woodcock, M.D., is the first recipient of the Personalized Medicine Coalition's award for Leadership in Personalized Medicine. The award, which cites Woodcock's pioneering initiatives to stimulate and guide development of novel medical therapies, is given to recognize contributions to advancement of medical science.

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01254.html

 

To view an archive of past FDA news releases, go to

http://www.fda.gov/opacom/hpnews.html.

 

To access the RSS feed of FDA news releases, go to

http://www.fda.gov/bbs/topics/news/rssPress.xml.

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

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RECALLS/SAFETY ALERTS

 

Recalls:

 

Worthington Choplets Vegetable and Grain Protein Patties; 1 lb. 4 oz. size

Reason for recall: undeclared egg and milk

http://www.fda.gov/oc/po/firmrecalls/worthington10_05.html

 

Golden Eagle Smoked Foods' smoked salmon, packed under the brand names Golden Eagle, Fjord, Hickory House, and Imperial

Reason for recall: possible Listeria monocytogenes contamination

http://www.fda.gov/oc/po/firmrecalls/goldeneagle11_05.html

 

Shampoo caps with conditioner made by Salus Corp.

Reason for recall: possible Serratia marcescens contamination

http://www.fda.gov/oc/po/firmrecalls/salus10_05.html

 

 

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated

products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.

 

To access the RSS feed of FDA recalls information, go to

http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml.

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

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CONGRESSIONAL TESTIMONY

 

Nov. 1 -- Acting FDA Associate Commissioner for Policy and Planning Randall W. Lutter, Ph.D., appeared before the House Subcommittee on Criminal Justice, Drug Policy, and Human Resources .

Subject: counterfeit drugs in the United States

http://www.fda.gov/ola/2005/counterfeit1101.html

 

To view an archive of past testimony by FDA officials, go to

http://www.fda.gov/ola/listing.html.

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UPCOMING PUBLIC MEETINGS

 

Nov. 7 -- International Conference on Harmonization Workshop on Oncolytic Viruses

Under discussion: issues relevant to clinical development of oncolytic viruses, including safety

Location: Chicago

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-19195.htm

 

Nov. 8 -- Oncologic Drugs Advisory Committee

Under discussion: pending applications for various medical products

Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cder12542d110805.html

 

Nov. 14 -- Prescription Drug User Fee Act (PDUFA) Public Meeting

Under discussion: stakeholder views as FDA prepares to work on amended authorizing legislation for PDUFA

Location: Bethesda, Md.

http://www.fda.gov/oc/meetings/pdufa111405.html

 

Nov. 17 -- Third Annual CDRH/CBER Medical Device User Fee and Modernization Act (MDUFMA) Stakeholder Meeting, a public gathering to obtain information from stakeholders on MDUFMA-related issues.

Location:  Gaithersburg, Md

http://www.fda.gov/cdrh/meetings/111705.html

 

Dec. 7-8 -- Hearing to obtain public input on the agency's current risk communications and outreach strategies, which include patient information sheets, press releases, public health advisories, and other tools.

Location: Washington, D.C.

http://www.fda.gov/bbs/topics/answers/2005/ans01367.html

 

Dec. 15 -- Joint FDA/USDA to discuss a consistent regulatory approach concerning the jurisdiction over certain products containing meat or poultry.

Location: Rosemont, Ill.

http://www.fda.gov/bbs/topics/news/2005/NEW01255.html

 

For a list of FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.

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QUESTION OF THE WEEK

 

How can you clean your hands when water is not available, such as when traveling or picnicking away from home?

You can use disposable wipes or a hand gel sanitizer. Use the gel without water. The alcohol in the gel kills the germs on your hands. You can find disposable wipes and hand gel sanitizers in most supermarkets and drugstores.                                                                          __________________________________________________

KIDS:

Do you go to school when you have a cold?  Let us know by taking our fun poll on FDA's Kids' Web site. Check it out at http://www.fda.gov/oc/opacom/kids/default.htm. Thanks!

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