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THIS WEEK'S
NEWS
-- South African Company Gets 'Tentative
Approval' for HIV
Regimen
-- Recalls/Market
Withdrawals
-- Public Meetings
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South African Company Gets
'Tentative Approval' for HIV Regimen
FDA has given "tentative approval"
to a drug regimen made by South Africa-based Aspen Pharmacare to treat HIV-1
infection in adults. The tentative
approval status means that though existing patents or exclusivity rights prevent
U.S. marketing of the regimen, the product meets FDA's standards for quality,
safety, and effectiveness. As such, it is available for procurement by the Bush
administration's Emergency Plan for AIDS Relief.
http://www.fda.gov/bbs/topics/news/2005/NEW01152.html
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RECALLS/MARKET
WITHDRAWALS
The following product is being
recalled for the reason shown. Go to the linked page for more
information.
Temple Brand Cooked Dry Peas
(potential environment for growth of harmful
microorganisms)
http://www.fda.gov/oc/po/firmrecalls/walong01_05.html
For a listing of recalls, market
withdrawals, and safety alerts from the last 60 days involving FDA-regulated
products, go to http://www.fda.gov/opacom/7alerts.html.
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PUBLIC
MEETINGS
Feb. 16-18 -- Joint Meeting of the FDA Arthritis
Drugs Advisory Committee and the Drug Safety and Risk Management Advisory
Committee: under discussion: benefit-to-risk considerations for COX-2
nonsteroidal anti-inflammatory drugs (Gaithersburg,
Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cder12532ddd0216171805.html
April 27-28 -- 11th Annual FDA Science Forum;
includes a free public session on personalizing your healthcare, and scientific
sessions on nanotechnology, animal models, cancer diagnosis/treatment, risk
management, and other topics (Washington,
D.C.)
http://www.cfsan.fda.gov/~frf/forum05/sxsf05pr.html
For a list of upcoming FDA meetings,
seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html.
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health-related topics such as antidepressants for children, dental braces, or
heart transplants? Find out by taking the FDA Consumer quiz at http://www.fda.gov/fdac/quiz/onlinequiz21_js.html.
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