FDA News Digest for February 7, 2005

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

Title: Message

FDA News Digest

February 7, 2005

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THIS WEEK'S NEWS

 

--  Proposed $1.9 Billion FY '06 Budget for FDA

    Would Boost Food Defense, Drug Safety 

--  FDA Renews Alert on 'IV Flush' Brand Preloaded Syringes

    In Light of New Reports of Contamination

--  FDA OKs First Generic Skin Patch to Treat Chronic Pain

--  Recalls/Market Withdrawals

--  Public Meetings

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Proposed $1.9 Billion FY '06 Budget for FDA

Would Boost Food Defense, Drug Safety

 

FDA's fiscal year 2006 budget request to Congress totals $1.9 billion, a 4.5 percent increase over the FY 2005. Included is a proposed increase of $30.1 million for efforts to defend the U.S. food supply from terrorist attacks; a nearly $6 million increase to advance FDA's medical device review process; and an additional $5 million to enhance the agency's surveillance activities concerning the safety of marketed drugs.

http://www.fda.gov/bbs/topics/news/2005/NEW01155.html

 

FDA Renews Alert on 'IV Flush' Brand Preloaded Syringes

In Light of New Reports of Contamination

 

FDA is reissuing a nationwide alert against the use of all lots of preloaded syringes containing either heparin or sodium chloride intravenous catheter flushes manufactured by the IV Flush, LLC and distributed by Pinnacle Medical Supply because of possible contamination with Pseudomonas fluorescens. Since FDA's initial warning on Jan. 31, there have been several new reports of infections in patients.

-- Feb. 4, 2005 release: http://www.fda.gov/bbs/topics/news/2005/NEW01154.html

-- Jan. 31, 2005 release: http://www.fda.gov/bbs/topics/news/2005/NEW01153.html

 

FDA OKs First Generic Skin Patch to Treat Chronic Pain

 

FDA has granted approval to Mylan Technologies Inc for the first generic version of Alza Corporation's Duragesic Patch (Fentanyl Transdermal System), a treatment for severe chronic pain that cannot be managed with other drugs. When applied to the skin, the patch delivers the drug fentanyl, which is slowly absorbed into the body for pain relief lasting up to three days.

http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01339.html

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RECALLS/MARKET WITHDRAWALS

 

The following products are being recalled for the reasons shown. Go to the linked pages for more information. 

 

Smak Marinated Mushrooms; 23.45-oz. and 30.5-oz. containers (undeclared sulfites)

http://www.fda.gov/oc/po/firmrecalls/royal02_05.html

 

CIBO Naturals Portabella Mushroom Grande Ravioli (undeclared lobster)

http://www.fda.gov/oc/po/firmrecalls/monterey01_05.html

 

Certain lots of Becton, Dickinson and Co. Urine Processing Kits (problems include increased indeterminate test results and increased false negatives) http://www.fda.gov/oc/po/firmrecalls/bd01_05.html

 

For a listing of recalls, market withdrawals, and safety alerts from the last 60 days involving FDA-regulated products, go to http://www.fda.gov/opacom/7alerts.html.

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PUBLIC MEETINGS

 

Feb 16-17 --  Meeting of the Vaccines and Related Biological Products Advisory Committee; under discussion: the selection of strains to be used in the 2005-2006 flu vaccine (Bethesda, Md.)                                                                                                             http://www.fda.gov/oc/advisory/accalendar/2005/cber12391dd02161705.html

Feb. 16-18 -- Joint Meeting of the FDA Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee: under discussion: benefit-risk considerations for COX-2 nonsteroidal anti-inflammatory drugs (Gaithersburg, Md.)                    http://www.fda.gov/oc/advisory/accalendar/2005/cder12532ddd0216171805.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 and treatment, risk management, and other topics (Washington, D.C.)                                                 http://www.cfsan.fda.gov/~frf/forum05/sxsf05pr.html

 

For a list of upcoming FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.

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