FDA News Digest for January 14, 2008

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

Title: FDA News Digest for January 14, 2008

FDA News Digest

January 14, 2008

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IN THIS WEEK'S ISSUE

 

»  News

    --  Companies Warned About Unsupported Hormone Therapy Claims

    --  Fourteen New Tests Licensed for Determining Blood Type

    --  'FDA Patient Safety News' Video, Podcast Available

»  Safety Alerts/Recalls

»  Upcoming Public Meetings

»  Consumer Health Information

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NEWS

 

Companies Warned About Unsupported Hormone Therapy Claims

FDA has sent letters warning seven pharmacy operations that claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT," products are unsupported by medical evidence, and that the agency considers these claims to be false and misleading. The pharmacy operations improperly claim that their drugs are superior to FDA-approved menopausal hormone therapy drugs and that they prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01772.html

 

Fourteen New Tests Licensed for Determining Blood Type

FDA has licensed 14 new tests for determining blood type, a process essential to a safe U.S. blood supply and safe transfusions. Knowing blood types for donors and patients is critical because patients may experience serious, possibly life-threatening, reactions from mismatched transfused blood.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01773.html 

 

'FDA Patient Safety News' Video, Podcast Available

FDA has posted the latest edition of "FDA Patient Safety News," a free Web-based video news program. Aimed primarily at health professionals, the program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls.

-- To view video or text version: http://www.fda.gov/psn

-- To access Podcast: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/podcast.cfm

 

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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SAFETY ALERTS/RECALLS

 

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

 

Jan. 23 -- Gastrointestinal Drugs Advisory Committee

    Under discussion: pending application for a new post-surgery drug

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-23177.htm

 

Feb. 1 -- Drug Safety and Risk Management Advisory Committee

    Under discussion: pending application for a new drug to treat iron deficiency anemia

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-24003.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 in FDA News Digest, we spotlight consumer health information by offering links to timely articles about FDA activities and products the agency regulates.

 

Here's what's in the spotlight this week:

 

›  Thyroid Medications: Q & A with Mary Parks, M.D.  

http://www.fda.gov/consumer/features/thyroid010208.html

›  New Studies on Anemia Drugs' Risks

http://www.fda.gov/consumer/updates/anemia010408.html

 

If you would like to sign up to receive all consumer updates, go to

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

 

Questions or comments about our consumer stories or the consumer health e-newsletter? Send an e-mail to fdaconsumerlist@xxxxxxxxxx.  

 

 

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