FDA News Digest for August 9, 2004

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FDA News Digest
August 9, 2004
________________________________________________

IN THIS WEEK'S ISSUE

--  Two Fixed-Dose Combination Drugs Approved to Treat HIV
--  Injectable Filler Sculptra Approved for HIV-Related Facial Wasting
--  FDA's Acting Commissioner Sets Agency Priorities for Next 6 Months
--  Recalls/Market Withdrawals
--  Public Meetings
--  Recent Speeches
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Two Fixed-Dose Combination Drugs Approved to Treat HIV

FDA has approved Epzicom and Truvada, two fixed-dose combination treatments
for HIV infection. Combination treatments bring together different HIV/AIDS
drugs in a single medication to help make treatment less complicated by
reducing the number of pills and times per day that patients need to take
them. Both of the new drugs are intended for use with other HIV/AIDS drugs.
http://www.fda.gov/bbs/topics/news/2004/NEW01099.html

Injectable Filler Sculptra Approved for HIV-Related Facial Wasting

Sculptra, an injectable filler, is the first product FDA has approved for
treating the facial wasting that is common among HIV-infected patients. It
has been shown to increase skin thickness, add volume to facial tissue, and
restore shape to facial areas with fat loss.
http://www.fda.gov/bbs/topics/news/2004/NEW02000.html

FDA's Acting Commissioner Sets Agency Priorities for Next 6 Months

Calling the next six months "a critical period," FDA Acting Commissioner
Lester M. Crawford, D.V.M., unveiled a lengthy list of agency priorities
Aug. 2 that he says will help "strengthen public health and build on [FDA's]
accomplishments in the recent past."  Priorities include: promoting faster
access to new medical technologies; issuing manufacturing practice guidance
for dietary supplement makers; helping make lower-cost medicines available
to as many people as possible; and proposing a clarification of nutrient
content claims related to the carbohydrate content of foods.
http://www.fda.gov/bbs/topics/news/2004/NEW01098.html
______________________________________________________________

RECALLS/MARKET WITHDRAWALS

The following products are being recalled for the reasons shown. Go to the
linked page for more information.

Minerva Patient Lifts; model numbers ML20 and ML30 (mechanical problems)
http://www.fda.gov/oc/po/firmrecalls/medibo08_04.html

Outta Hand Ceramic Porcelain Cocktail Plates (high lead levels)
http://www.fda.gov/oc/po/firmrecalls/axis08_04.html

Roxy Brand White Sesame Seeds (possible Salmonella contamination)
http://www.fda.gov/oc/po/firmrecalls/roxy08_04.html


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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PUBLIC MEETINGS

Sept. 20-24 -- 2004 PDA/FDA Joint Regulatory Conference; Washington, D.C.
http://www.pda.org/pdafda2004/index.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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RECENT SPEECHES

FDA Acting Commissioner Lester M. Crawford, D.V.M, before the National
Medical Association, House of Delegates Meeting, San Diego (Aug. 4)
http://www.fda.gov/oc/speeches/2004/nma0804.html

FDA Acting Commissioner Lester M. Crawford, D.V.M.; Newsmaker Luncheon,
National Press Club, Washington, D.C. (Aug. 2)
http://www.fda.gov/oc/speeches/2004/bascrty0707.html

To view an archive of speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm
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