FDA News Digest for February 19, 2008

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA News Digest for February 19, 2008

 

FDA News Digest

February 19, 2008

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IN THIS WEEK'S ISSUE

 

»  News

    -- Practices Proposed for Articles on Unapproved Uses of Medical Products

»  Safety Alerts/Recalls

»  Upcoming Public Meetings

»  Consumer Health Information

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NEWS

 

Practices Proposed for Articles on Unapproved Uses of Medical Products

FDA is proposing "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices. The proposed practices include ensuring that the article or reference be published by an organization that has an editorial board. The organization also should fully disclose any conflicts of interest or biases for all authors, contributors or editors associated with the journal article.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01798.html

 

To view an archive of recent 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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SAFETY ALERTS/RECALLS

Food Recalls:

 

› Pokémon-branded “Valentine Cards and Pops” (two package sizes)

Reason for recall: reports of metal fragments found in product

http://www.fda.gov/oc/po/firmrecalls/sherwood02_08.html

› See's Semi-Sweet Chocolate Chips, 16-oz. size

Reason for recall: milk component not declared on label

http://www.fda.gov/oc/po/firmrecalls/sees02_08.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

 

Feb. 27-28 -- Anti-Infective Drugs Advisory Committee

    Under discussion: two pending applications for skin/skin structure infection treatments

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-343.htm

 

March 11 -- Anesthetic and Life Support Drugs Advisory Committee

    Under discussion: pending application for a new drug

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-1239.htm

 

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

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

 

 

CONSUMER HEALTH INFORMATION

 

Each week, we spotlight offer links to timely articles about FDA activities and products the agency regulates. In the spotlight this week:

 

› Celebrating the Successes of the Orphan Drug Act

http://www.fda.gov/consumer/updates/oda020808.html

› “My Medicines”…This Brochure Can Be a Lifesaver

http://www.fda.gov/consumer/updates/mymedsbrochure021508.html

 

To receive all consumer updates, go to

http://www.fda.gov/consumer/consumerenews.html  

 

 

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Our next issue will be sent February 25.

 

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