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Last Updated: Nov 25th, 2007 - 10:09:00

FDA News Digest

November 22, 2004

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IN THIS WEEK'S ISSUE

-- FDA Responds to Allegations About Vioxx, Drug Safety

-- Rules Finalized to Improve Safety of Human Donor Cells, Tissue

-- 'Smart' Tags to Help Avoid Surgical Errors, Identify Rx Drugs

-- FDA Proposes Guidance for Evaluating New Proteins in Plants

-- Lung Cancer Drug Tarceva Approved; Shows Improved Survival

-- Labeling Changes Announced for Mifepristone, Depo-Provera

-- Recalls/Market Withdrawals

-- Congressional Testimony

-- Public Meetings

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FDA Responds to Allegations About Vioxx, Drug Safety

Three FDA officials have responded to allegations related to the approval and postmarket review of the arthritis drug Vioxx, and about the agency's drug safety activities in general. Included is a statement by Steven Galson, M.D., acting director of the FDA Center for Drug Evaluation and Research, that recent congressional testimony by David Graham, M.D., associate director of the FDA Office of Drug Safety, does not reflect the agency's views.

-- Statement by FDA Acting Commissioner Lester M. Crawford, D.V.M.: http://www.fda.gov/bbs/topics/news/2004/NEW01136.html

-- Statement by Acting Director of the FDA Center for Drug Evaluation and Research Steven Galson, M.D.: http://www.fda.gov/bbs/topics/news/2004/NEW01138.html

-- Testimony by Deputy Director of the FDA Office of New Drugs Sandra Kweder, M.D.: http://www.fda.gov/ola/2004/vioxx1118.html

Rules Finalized to Improve Safety of Human Donor Cells, Tissue

FDA has finalized the last of three rules in its plan to improve the safety of a broad range of human donor cell and tissue products. These products include musculoskeletal tissue, corneas, human heart valves, dura mater (brain lining), and cellular therapies.

-- Press release: http://www.fda.gov/bbs/topics/news/2004/NEW01137.html

-- Questions and answers: http://www.fda.gov/cber/rules/gtpq&a.htm

'Smart' Tags to Help Avoid Surgical Errors, Identify Rx Drugs

FDA has cleared for marketing a tag that uses "smart" technology to mark an anatomical site for surgery. Called the SurgiChip Tag Surgical Marker system, the device is intended to minimize the chance of wrong-site, wrong-procedure, or wrong-patient surgeries. It is the first such marker to use radio frequency identification (RFID), a burgeoning technology with many future applications, including tags for prescription drugs to help thwart counterfeiters.

-- Surgical tag: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01326.html

-- Prescription drugs tag: http://www.fda.gov/bbs/topics/news/2004/NEW01133.html

FDA Proposes Guidance for Evaluating New Proteins in Plants

To help ensure that material from new plant varieties intended for food use doesn't accidentally enter the food supply before FDA has evaluated its safety, the agency has proposed an industry guidance that describes how companies should consult with FDA early in product development.

http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01327.html

Lung Cancer Drug Tarceva Approved; Shows Improved Survival

FDA has approved Tarceva tablets to treat non small-cell lung cancer, the most common form of lung cancer in the United States. The drug is intended for patients whose cancer has progressed despite other treatments, including at least one chemotherapy regimen. In clinical trials, the drug was shown to improve survival time.

http://www.fda.gov/bbs/topics/news/2004/NEW01139.html

Labeling Changes Announced for Mifepristone, Depo-Provera

FDA has announced that the labeling for Mifepristone, approved for termination of early pregnancy, will include new information on possible adverse effects, including the risk of serious bacterial infections, sepsis, bleeding, and death. Also announced was new "black box" labeling for the contraceptive Depo-Provera, warning that prolonged use may result in loss of bone density.

-- Mifepristone: http://www.fda.gov/bbs/topics/news/2004/NEW01134.html

-- Depo-Provera: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01325.html

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RECALLS/MARKET WITHDRAWALS

No recall press releases were issued in the past week. 

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the last 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

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CONGRESSIONAL TESTIMONY

FDA Acting Commissioner Lester M. Crawford, D.V.M., before the Senate Special Committee on Aging; subject: FDA's ongoing efforts to ensure the safety, effectiveness, and availability of influenza and other vaccines (Nov. 16)

http://www.fda.gov/ola/2004/vaccines1116.html

To view an archive of FDA congressional testimony, go to http://www.fda.gov/ola/listing.html

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PUBLIC MEETINGS

Dec. 2 -- Advisory Committee for Reproductive Health Drugs; under discussion: pending application for a testosterone patch for surgically menopausal women (Gaithersburg, Md.)

http://www.fda.gov/oc/advisory/accalendar/2004/cder12537d120204.html

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

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