FDA News Digest
September 26,
2005
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IN THIS WEEK'S ISSUE
-- FDA Says Inamed's Silicone Breast Implants Are 'Approvable'
-- First Pediatric Generic AIDS Drug Approved for U.S. Marketing
-- Throckmorton Chosen Deputy Director of FDA Drugs Center
-- Recalls/Safety Alerts
-- Congressional Testimony
-- Public Meetings
-- Question of the
Week
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FDA Says Inamed's Silicone Breast Implants Are 'Approvable'
FDA has issued an "approvable" letter to Inamed Corp. for its application to market silicone gel-filled breast implants. An approvable letter is one of several steps in the FDA review process for new products. The letter does not mean that FDA has approved the implants for marketing at this time. Inamed is the second implant maker in recent weeks to receive an approvable letter. Mentor Corp. received one in August.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01233.html
First Pediatric Generic AIDS Drug Approved for U.S. Marketing
FDA has approved several generic versions of zidovudine, a drug that treats HIV and AIDS. Previously, these products had only received tentative approval because patent or market exclusivity prevented full marketing approval. But those patents have now expired, clearing the way for the full approval. Zidovudine is in a class of drugs that helps keep the AIDS virus from replicating and is typically used with other drugs to treat HIV infection.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01232.html
Throckmorton Chosen Deputy Director of FDA Drugs Center
FDA has named Douglas Throckmorton, M.D., deputy director of the agency's Center for Drug Evaluation and Research. He has served in that position in an acting capacity since May 2004 and has held other management positions within the drugs center since 1997. Throckmorton also serves as the founding chair of the recently established FDA Drug Safety Oversight Board.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01234.html
To view an archive of past FDA news
releases, go to
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RECALLS/SAFETY ALERTS
All injectable products made by Central Admixture Pharmacy Services Inc.
Reason for recall: possible sterility problems
http://www.fda.gov/medwatch/safety/2005/safety05.htm#CAPS
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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http://www.fda.gov/ola/listing.html.
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Sept. 27 -- General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee
Under discussion: FDA's Critical Path initiative
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12520d092705.html
Sept. 29 -- Blood Products Advisory Committee
Under discussion: a proposed treatment for chronic iron overload due to blood transfusions
Location: Rockville, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cber19516d092905.html
Sept. 29 -- Research Review Subcommittee of the Cellular, Tissue and Gene Therapies Advisory Committee
Under discussion: the research program at FDA's Office of Cellular, Tissue and Gene Therapies
Location: Bethesda, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cber12389d092905.html
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
Can the symptoms of foodborne
illness be mistaken for something else?
Yes. Foodborne illness
often shows itself as flu-like symptoms such as nausea, vomiting, diarrhea, or
fever, so many people may not recognize that the illness is caused by bacteria
or other pathogens in food.
The Centers for Disease
Control and Prevention (CDC) reports that
many of the intestinal illnesses commonly referred to as stomach flu are
actually caused by foodborne pathogens. People do not associate these
illnesses with food because the onset of symptoms often occurs two or more days
after the contaminated food was eaten.
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