FDA News
Digest
April 4,
2005
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IN THIS WEEK'S ISSUE
-- Albuterol Inhalers With CFC Propellants to be Phased Out
-- New Drug Slows Progression of Hepatitis B Virus
-- FDA Asks
Public for Comments on Proposed Food Label Changes
--
Recalls/Market Withdrawals
-- Recent
Speeches
-- Public
Meetings
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Albuterol Inhalers With CFC Propellants to be Phased Out
FDA has published a final rule directing makers of albuterol metered-dose inhalers with chlorofluorocarbon (CFC) propellants to stop selling the products by Dec. 31, 2008. The inhalers are used to treat patients with asthma and chronic obstructive pulmonary disease. They are being phased out because the CFC propellant can deplete the Earth's protective ozone layer. At least two non-CFC albuterol inhalers will be available by the phase-out date, FDA says.
-- Press release: http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01349.html
-- Questions and answers: http://www.fda.gov/cder/mdi/mdifaqs.htm
New Drug Slows Progression of Hepatitis B Virus
FDA has approved Baraclude (entecavir) for treating chronic hepatitis B in adults. Hepatitis B can cause cirrhosis (scarring) of the liver, liver cancer, liver failure, and death. Baraclude slows progression of the disease by interfering with reproduction of the hepatitis B virus.
http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01348.html
FDA Asks Public for Comments on Proposed Food Label Changes
FDA is asking for public comment on two proposals to improve the appearance and content of the nutrition label. The changes are aimed at helping consumers make better-informed decisions about weight management. FDA will accept comments until mid-June.
http://www.fda.gov/bbs/topics/news/2005/NEW01170.html
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RECALLS/MARKET
WITHDRAWALS
The following
product is being recalled for the reason shown. Go to the linked page for
more information.
One lot of Five Star
Fruit & Nut Bars, 2-oz. size (undeclared peanuts)
http://www.fda.gov/oc/po/firmrecalls/lakechamplain03_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 Pharmaceutical
Education Associates (March 22)
http://www.fda.gov/oc/speeches/2005/pea0322.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 --
Cardiovascular and
Renal Drugs Advisory Committee; under discussion: proposed labeling changes for
two new uses of the drug Norvasc (Gaithersburg, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cder12533d040505.html
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 7 --
Allergenic Products
Advisory Committee; under discussion: proposed strategy for reclassification of
Class IIIA allergenic products and an update of the FDA Critical Path Initiative
(Bethesda, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cber12388d040705.html
April 11-13 --
General and Plastic
Surgery Devices Panel of the Medical Devices Advisory Committee; under
discussion: two pending
applications for approval of silicone gel-filled breast prostheses
(Gaithersburg, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12519ddd0411121305.htmlhttp://www.fda.gov/opacom/hpmeetings.html
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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