FDA News Digest for March 19, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

March 19, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- FDA Clears New Rapid Test to Detect Viral Meningitis

    -- Strengthened Labeling Requested for Sleep Disorder Drugs

    -- First-of-its-Kind Drug Approved to Treat Rare Blood Disorder

»  Recalls/Safety Alerts

»  Congressional Testimony

»  Upcoming Public Meetings

»  Question of the Week

»  New Postings on FDA.gov

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NEWS

 

FDA Clears New Rapid Test to Detect Viral Meningitis

FDA has cleared for marketing the Xpert EV test, which can help quickly detect viral meningitis. When used with other tests, the Xpert EV test can help doctors distinguish between viral meningitis and the less common, but more severe, bacterial meningitis. Current diagnostic tests for meningitis can take up to a week, but results from the Xpert EV test are available in 2-1/2 hours.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01588.html 

 

Strengthened Labeling Requested for Sleep Disorder Drugs

FDA has requested all makers of sedative-hypnotic drug products, a class of drugs used to maintain or induce sleep, to include stronger language on their products about potential risks. These risks include severe allergic reactions and complex sleep-related behaviors such as driving when not fully awake, with no memory of the event, after taking a sedative-hypnotic drug.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html

 

First-of-its-Kind Drug Approved to Treat Rare Blood Disorder

FDA has approved Soliris (eculizumab) to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder that can lead to disability and premature death. PNH is characterized by red blood cells that develop abnormally, ultimately causing anemia. Soliris does not cure PNH, but it treats the breakdown of red blood cells. PNH affects about one in a million persons in the United States.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01589.html

 

To view an archive of past FDA news releases, go to

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

 

To access the RSS feed of FDA news releases, go to

http://www.fda.gov/bbs/topics/news/rssPress.xml.

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

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RECALLS/SAFETY ALERTS

Pet Food Recall:

 

Following the reported deaths of nine cats and one dog possibly linked to pet food consumption, Canadian manufacturer Menu Foods Inc. is recalling all its "cuts and gravy"-style dog and cat food produced at the company's Kansas facility between Dec. 3, 2006, and March 6, 2007. At press time, the cause of the pet deaths had not been determined. The products are packaged in cans and pouches under various brands and are marketed nationwide by many retailers. FDA urges consumers who have any of these products to stop feeding them to pets.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01590.html 

-- List of affected products: http://www.menufoods.com/recall/

-- More information: http://www.fda.gov/oc/opacom/hottopics/petfood.html

 

Food Recalls:

 

Ben & Jerry's Country Peach Cobbler Ice Cream, one pint size

    Reason for recall: undeclared wheat

http://www.fda.gov/oc/po/firmrecalls/benjerry03_07.html

 

Certain lots of Coborn's, Cash Wise, and Midwest Pride potato salad (sold in Minnesota and six other states)

    Reason for recall: possible Listeria monocytogenes contamination

http://www.fda.gov/oc/po/firmrecalls/mda03_07.html

 

Gretchen's Shoebox Express Tuna & Garden Salad Mixer (sold exclusively for Amtrak trains)

    Reason for recall: undeclared soy

http://www.fda.gov/oc/po/firmrecalls/gretchen03_07.html

 

 

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated

products from the past 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

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

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CONGRESSIONAL TESTIMONY

 

FDA Commissioner Andrew C. von Eschenbach, M.D., appeared before the Senate Committee on Health, Education, Labor and Pensions

    Subject: reauthorization of the Prescription Drug User Fee Act

http://www.fda.gov/ola/2007/pdufa031407.html

 

To view an archive of past testimony by FDA officials, go to

http://www.fda.gov/ola/listing.html

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UPCOMING PUBLIC MEETINGS

 

March 29 -- Anesthetic and Life Support Drugs Advisory Committee

    Under discussion: findings of nervous system degeneration in juvenile animals exposed to anesthetic drugs and relevance to pediatric patients

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-1991.htm

 

March 29 -- Food Defense Workshop

    Under discussion: regulations authorized by the Bioterrorism Act of 2002 and other subjects related to FDA-regulated food facilities

    Location: Dallas

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-19886.htm

 

April 10-11 -- Food Labeling Workshop (jointly sponsored by FDA and the University of Arkansas

    Under discussion: FDA food labeling regulations, especially as they relate to small businesses and startups

    Location: Fayetteville, Ark.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-1570.htm

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

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

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QUESTION OF THE WEEK

 

What is the proper temperature for my refrigerator?

 

Refrigerators should stay at 41 degrees F (5 degrees C) or below. That temperature range will slow the growth of most bacteria. It won't kill the bacteria, but it will keep them from multiplying, and the fewer there are, the less likely you are to get sick from them.

 

Freezing at zero degrees F (minus 18 degrees C) or less stops bacterial growth, although it won't kill all bacteria already present.

 

For more on food safety, see http://www.foodsafety.gov/.

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NEW POSTINGS ON FDA.GOV

 

FDA has recently launched:

 

»  a Web site with links to information about the agency's

pandemic flu programs

http://www.fda.gov/oc/op/pandemic/default.htm

 

»  A revised Newsroom page with links to press releases,

recalls information, Podcasts, RSS feeds, and more

http://www.accessdata.fda.gov/news/

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