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FDA News Digest
January 8, 2007
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IN THIS WEEK'S
ISSUE
» News
-- FDA Proposes Health Claim for Calcium, Vitamin D
-- First Drug Approved for Treating Obesity in Dogs
-- Latest 'Patient Safety News' Video Available Online
» Recalls/Safety
Alerts
» Upcoming Public Meetings
» Question of the
Week
FDA has posted the latest edition of "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.
http://www.fda.gov/psnhttp://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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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. 9 -- Public Workshop on Marketed Unapproved Drugs
Under discussion: how businesses can obtain FDA approval to legally market currently unapproved drug products
Location: Rockville, Md.
-- Press release: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01500.html
-- Federal Register notice: http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-17959.htm
Jan. 23-24 -- Reproductive Health Drugs Advisory Committee
Under discussion: oral and non-oral hormonal contraceptives
Location: Rockville, Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-21949.htm
Jan. 26 -- Neurological Devices Panel of the Medical Devices Advisory Committee
Under discussion: pending application for a medical device that treats depression
Location: Gaithersburg, Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-20552.htm
Feb. 7-8 -- Industry Exchange Workshop on FDA Clinical Trial Requirements
Under discussion: various aspects of establishing and conducting clinical trials including ethics, informed consent, and FDA's role
Location: San Diego
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-21138.htm
For a list of FDA meetings, seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html.
QUESTION OF THE WEEK
What risks are involved with
taking counterfeit medications?
Patients taking counterfeit
medicines may experience unexpected side effects, allergic reactions, or a
worsening of their medical condition. Some counterfeits do not contain any
active ingredients, and instead contain inert substances, which do not provide
the patient any treatment benefit. Counterfeit medications may also contain
incorrect ingredients, improper dosages of the correct ingredients, or hazardous
ingredients.
The extent of the problem of
counterfeit drugs is unknown. Counterfeiting is difficult to detect, investigate
and quantify. What is known is that they occur worldwide and are more prevalent
in developing countries. It is estimated that upwards of 10 percent of drugs
worldwide are counterfeit, and in some countries more than half of the drug
supply is made up of counterfeit drugs. Counterfeiting occurs less frequently in
the
For more on counterfeit drugs, see http://www.fda.gov/counterfeit/.
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