FDA News Digest for November 13, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

November 13, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- Program Bolstered for Monitoring Devices After Marketing

    -- FDA Seeks Injunction of Minnesota Seafood Processor

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

Program Bolstered for Monitoring Devices After Marketing

FDA has created an action plan designed to strengthen the way the agency monitors medical devices and radiation-emitting products after they have been approved for marketing. The plan will help FDA identify, analyze and act on potential risks posed by the thousands of devices health professionals and consumers use daily.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01506.html

 

FDA Seeks Injunction of Minnesota Seafood Processor

Following repeated inspections, which revealed that Minneapolis-based Worldwide Fish & Seafood had failed to establish a plan to prevent and control safety hazards related to its products, FDA has filed in U.S. district court for an injunction against the company. FDA says the company's actions pose a public health risk because conditions could develop that would allow seafood products to be contaminated with potentially harmful bacteria.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01505.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

Drug Recall:

 

Acetaminophen caplets (500 mg), distributed by Perrigo Co. and sold under numerous store-brand names; about 11 million bottles affected

    Reason for recall: small metal fragments found in a small number of caplets

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01507.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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UPCOMING PUBLIC MEETINGS

Nov. 15-16 -- Detroit District Workshop on FDA Clinical Trial Statuary and Regulatory Requirements

    Under discussion: FDA regulation of clinical research conduct, informed consent requirements, other topics

    Location: Indianapolis

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-13114.htm

 

Nov. 16 -- Immunology Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for diagnostic test for metastatic breast cancer

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-16319.htm

 

Nov. 29 -- Arthritis Advisory Committee

    Under discussion: pending application for drug to treat juvenile rheumatoid arthritis

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/06-8787.htm

 

Dec. 7-8 -- Circulatory System Devices Panel of the Medical Devices Advisory Committee

    Under discussion: issues related to thrombosis in coronary drug-eluting stents

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-17519.htm

 

Jan. 9 -- Public Workshop on Marketed Unapproved Drugs

    Under discussion: how businesses can obtain FDA approval to legally market currently unapproved drug products

    Location: Rockville, Md.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01500.html

-- Federal Register notice: http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-17959.htm

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

 

What are FDA advisory committees? How can I find out when they meet?

FDA enlists non-government experts from across the country to help the agency reach decisions, particularly concerning controversial issues or new and unusual products. These "advisory committees" consist of medical professionals, scientists, researchers, industry leaders, consumers, and patients.

 

To learn more about advisory committees, and to see a list of meeting dates, go to http://www.fda.gov/oc/advisory/default.htm.

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       To learn more about FDA's 100th birthday,

     go to http://www.fda.gov/centennial/default.htm