FDA News
Digest
March 28,
2005
________________________________________________________
IN THIS WEEK'S ISSUE
-- FDA Guidance Aims to Help Speed 'Personalized' Medicine
-- Risk Minimization Guidance Issued to Help Boost Drug Safety
-- Novel Device Approved to Treat Aneurysms in Thoracic Aorta
--
Combating Obesity, Fighting Fake Drugs Among '04
Accomplishments
-- Seven Deaths Prompt Seizure of Faulty Hospital
Beds
-- Recalls/Market Withdrawals
-- Recent
Speeches
-- Public
Meetings
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FDA Guidance Aims to Help Speed
'Personalized' Medicine
FDA has issued guidance that will
help allow medicines to be uniquely crafted to maximize their therapeutic
benefits and minimize their risks to each patient. Called
pharmacogenomics, this emerging field can, for example, help identify
cancers that have a good chance of responding to a particular medicine or
regimen.
http://www.fda.gov/bbs/topics/news/2005/NEW01167.html
Risk Minimization Guidance Issued
to Help Boost Drug Safety
FDA has issued three final guidance
documents to help develop new and improved ways to assess and monitor
risks associated with drugs and biological products. Included are provisions
dealing with safety reporting during drug development, improved analysis of data
developed in pre-approval safety evaluations, and consistent use and
definition of terms.
http://www.fda.gov/bbs/topics/news/2005/NEW01169.html
Novel Device Approved to Treat
Aneurysms in Thoracic Aorta
FDA has approved the GORE TAG
Endoprosthesis System, designed to prevent ruptures of
descending thoracic aneurysms by creating a new path for blood flow. A
thoracic aortic aneurysm is a weakened, diseased and
bulging section of the aorta in the chest. Untreated, it could rupture and
cause life-threatening internal bleeding.
http://www.fda.gov/bbs/topics/news/2005/NEW01168.html
Combating Obesity, Fighting
Fake Drugs Among '04 Accomplishments
In 2004, FDA advanced public health
by creating new initiatives and revamping existing ones. These included programs
to combat critical health threats such as obesity, counterfeit drugs and medical
errors. The agency also strengthened the nation's food supply against
bioterrorism threats and streamlined paperwork processes.
http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01346.html
Seven Deaths Prompt Seizure of Faulty Hospital Beds
FDA and the Justice Department have
initiated seizures of Vail 500, 1000 and 2000 Enclosed Bed Systems
after determining that patients using these products can become
entrapped and suffocate, causing severe neurological damage or death. FDA has
learned of 30 entrapments, including seven deaths, resulting from use of the
beds.
http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01347.html
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RECALLS/MARKET
WITHDRAWALS
The following products
are being recalled for the reasons shown. Go to the linked page for more
information.
B-Sure One-Step Home
Pregnancy Test (safety, effectiveness questionable)
http://www.fda.gov/oc/po/firmrecalls/harmonybrands03_05.html
Rose Art
Design-a-Face Makeup (adverse skin reactions)
http://www.fda.gov/oc/po/firmrecalls/roseart03_05.html
Custom
Sugar Pre-Cut Frozen Cookie Dough (undeclared
egg)
http://www.fda.gov/oc/po/firmrecalls/best03_05.html
Merex Corp. 1-lb.
containers of dried apricots (undeclared sulfites)
http://www.fda.gov/oc/po/firmrecalls/merex03_05.html
Casa Imports Casale Sun-Dried
Tomatoes (undeclared sulfites)
http://www.fda.gov/oc/po/firmrecalls/casa03_05.html
Mama's Smoked Nova
Salmon (possible Listeria monocytogenes
contamination)
http://www.fda.gov/oc/po/firmrecalls/seaspecialties03_05.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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RECENT
SPEECHES
Acting FDA
Commissioner Lester M. Crawford, D.V.M., before the 2005 Food Safety Summit
(March 18)
http://www.fda.gov/oc/speeches/2005/foodsafety0318.html
To view an archive of
past speeches by FDA officials, go to http://www.fda.gov/speeches/speechli.htm
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PUBLIC
MEETINGS
April 5-6 --
Animal Feed Safety
System: A Comprehensive Risk-Based Safety Program for the Manufacture and
Distribution of Animal Feeds; a forum for comments on a safety program designed
to minimize public health hazards posed by animal feed products (Omaha,
Neb.)
http://www.fda.gov/cvm/index/animalfeed/AFSSMtg/AFSSMtg042005.htm
April 5-6 --
FDA/University of
Arkansas workshop on food labeling; intended to provide information about FDA
food labeling regulations and related subjects to regulated industry, especially
small businesses and startups (Fayetteville, Ark.)
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-2299.htm
April 26-28 --
11th Annual FDA
Science Forum; includes a free public session April 26 on personalizing your
healthcare; remaining two days are devoted to 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 FDA
meetings, seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html
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