FDA News
Digest
February 22, 2005
__________________________________________________________
IN THIS WEEK'S ISSUE
-- President Nominates
Lester M. Crawford to Be FDA Commissioner
-- New Board Will
Oversee Management of Drug Safety Monitoring
-- Fellowship Program
to Bridge Research, Regulation in Cancer Product
Development
-- New Product
Approved to Treat Rare Smallpox Vaccination Complications
-- Recalls/Market
Withdrawals
-- Recent
Speeches
-- Public
Meetings
__________________________________________________________
President Nominates
Lester M. Crawford to Be FDA Commissioner
President Bush has
nominated Lester M. Crawford, D.V.M., to be the next FDA commissioner. Crawford
has served as the agency's acting commissioner since March 2004. He has a wide
range of experience in government and academic positions. Crawford's nomination
has been sent to the Senate for the confirmation process.
-- Statement by HHS
Secretary Leavitt: http://www.hhs.gov/news/press/2005pres/20050214.html
-- Crawford biography:
http://www.fda.gov/oc/crawford/bio.html
New Board Will Oversee
Management of Drug Safety Monitoring
FDA has unveiled a
program that aims to improve oversight of drug safety monitoring and to bolster
openness in agency product review and decision-making. Included is creation of
an independent Drug Safety Oversight Board, made up of medical experts from FDA
and other government agencies. Also planned are Web postings of emerging drug
data and risk information, as well as written materials that provide targeted
drug safety information to the public.
http://www.fda.gov/oc/factsheets/drugsafety.html.
Fellowship Program to
Bridge Research, Regulation in Cancer Product
Development
FDA and the National
Cancer Institute have created a fellowship program that will help prepare for
the new generation of molecular-based cancer products. The program will train
cancer product researchers to bridge processes from scientific discovery through
clinical development and regulatory review. The goal is to help advance new
products by exposing researchers to regulatory requirements in the early stages
of cancer product development.
-- Press release: http://www.fda.gov/bbs/topics/news/2005/hhs_021605.html
-- Questions and
answers: http://www.fda.gov/oc/factsheets/iotfqanda.html
New Product Approved
to Treat Rare Smallpox Vaccination Complications
FDA has approved
Vaccinia Immune Globulin Intravenous (VIGIV), the first human plasma-derived
product available to treat certain rare complications of smallpox vaccination.
The product increases levels of protective antibodies against the vaccinia
virus, which is used in the current smallpox vaccine. Though the vaccine
contains a weakened form of the virus, it sometimes can cause infections in
people with suppressed immune systems or skin conditions. VIGIV may help
minimize these risks.
http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01341.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.
Certain models of
Medtronic Inc. implantable cardioverter-defibrillators and cardiac
resynchronization therapy defibrillators (potential battery shorting
problem)
http://www.fda.gov/oc/po/firmrecalls/medtronic02_05.html
Russell Hobbs Mona
Cordless Jug Kettles (may leach lead)
http://www.fda.gov/oc/po/firmrecalls/salton02_05.html
Fortuner's brand Dried
Honeysuckle and BiFeng brand Dried Potato (undeclared
sulfites)
http://www.fda.gov/oc/po/firmrecalls/greatkingsland02_05.html
Gano Cafe 3-in-1, Gano
Cafe Ginseng Tongkat Ali, and Gano C'real Spirulina Oats (undeclared
milk)
http://www.fda.gov/oc/po/firmrecalls/GanoExcel02_05.html
The Boy's Farmer
Market brand of smoked nova salmon (possible Listeria monocytogenes
contamination)
http://www.fda.gov/oc/po/firmrecalls/farmermarket02_05.html
NY Fish Inc.'s Salt
Cured Herring (possible Clostridium botulinum
contamination)
http://www.fda.gov/oc/po/firmrecalls/nyfish02_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
FDA Acting Commissioner Lester M.
Crawford, D.V.M., at an FDA "all-hands" briefing with Health and Human Services
Secretary Mike Leavitt (Feb. 15)http://www.fda.gov/oc/speeches/2005/safedrugs0215.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
Feb. 24 --
Meeting of the
Cardiovascular and Renal Drugs Advisory Committee; under discussion: pending
applications for approval to treat congestive heart failure with hypertension
drug Atacand (Rockville, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cder12533d022405.html
April 27-28 -- 11th Annual FDA Science Forum;
includes a free public session on personalizing your healthcare, and 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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