RECALLS- FDA News Digest for April 4, 2005

[Guest guest]

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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