FDA News Digest
November 27, 2006
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IN
THIS WEEK'S ISSUE
»
News
-- Generic Version of Drug
OK'd for Easing Chemotherapy Effects
-- Web Pages Give Background
on Recently Approved Devices
» Recalls/Safety
Alerts
» Recent
Speeches
» Congressional
Testimony
» Upcoming Public Meetings
» Question of the
Week
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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http://www.fda.gov/oc/po/firmrecalls/goldenglen11_06.html
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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RECENT SPEECHES
Nov. 16 -- FDA Acting Commissioner Andrew von Eschenbach, M.D., spoke at the Inaugural International Summit.
Subject: "The Challenges of Regulation in the World of Molecular Medicine"
http://www.fda.gov/oc/speeches/2006/summit111606.html
Nov. 13 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke before the Manhattan Institute
Subject: "New Steps to Improve Drug Safety"
http://www.fda.gov/oc/speeches/2006/manhattaninst1113.html
http://www.fda.gov/speeches/speechli.htm.
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CONGRESSIONAL TESTIMONY
Nov. 15 -- FDA Center for Food Safety and Applied Nutrition Director Robert E. Brackett, Ph.D., appeared before the Senate Health, Education, Labor, and Pensions Committee.
Subject: Lessons learned from recent outbreak of E. coli O157:H7 sickness linked to contaminated fresh spinach
http://www.fda.gov/ola/2006/foodsafety1115.html
To
view an archive of past testimony by FDA officials, go to
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UPCOMING PUBLIC MEETINGS
Nov. 29 -- Arthritis Advisory Committee
Under discussion: pending application for drug to treat juvenile rheumatoid arthritis
Location: Gaithersburg, Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/06-8787.htm
Dec. 6 -- Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee
Under discussion: HDL/LDL cholesterol tests; FDA's Critical Path initiative
Location: Gaithersburg, Md.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=613
Dec. 6 -- Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
Under discussion: trials for new drugs to treat pediatric brain cancer
Location: Rockville, Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-18442.htm
Dec. 7-8 -- Circulatory System Devices Panel of the Medical Devices Advisory Committee
Under discussion: issues related to blood clotting in coronary drug-eluting stents
Location: Gaithersburg, Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-17519.htm
Dec. 18 -- Public hearing to solicit comments on electronic submission of premarket material and other regulatory information
Location: Rockville, Md.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01510.html
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
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
can I do to protect myself and my family from food
tampering?
Consumers are the final judges of
food safety. An essential step for tampering protection is to check
whether the food container is intact
before opening it. If it has been damaged, dented or opened prior to
purchase, don't use the contents. Be alert also to abnormal odor,
taste and appearance of a food item. If there is any doubt about its safety,
don't eat it. If the food appears to have been tampered with, report it to one
of these authorities:
» If the suspected food product does NOT contain meat or
poultry, consumers should call the FDA 24-hour emergency number
at (301) 443-1240, or call the consumer complaint
coordinator at the nearest FDA district office (listed in most phone
directories).
» If the food product DOES contain meat or poultry, call
the U.S. Department of Agriculture's Meat and Poultry Hotline at (800)
535-4555.
For more on food tampering, see http://www.cfsan.fda.gov/~dms/fstamper.html.
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DON'T LET THE FLU RUIN YOUR HOLIDAYS! Get a flu vaccine. For more information, see http://www.fda.gov/oc/opacom/hottopics/flu.html or http://www.cdc.gov/flu.
National Influenza Vaccination Week, Nov. 27 - Dec. 3.
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