FDA News Digest for July 23, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

July 23, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    --  FDA Approves First Artificial Disc to Treat Common Cause of Neck, Arm Pain

»  Safety Alerts/Recalls

»  Congressional Testimony 

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

FDA Approves First Artificial Disc to Treat Common Cause of Neck, Arm Pain

FDA has approved the Prestige Cervical Disc, the first artificial cervical (neck) disc for treating cervical degenerative disc disease, one of the most common causes of neck and arm pain. FDA based its approval on a clinical study of 541 patients showing that the device improved neck or arm pain and was as safe and effective as the current treatment of cervical fusion.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01668.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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SAFETY ALERTS/RECALLS

Safety Alert:

 

›  FDA is warning consumers that various canned food products and dog food made by Castleberry's Food Co. should be thrown away due to the risk of botulism poisoning. The company is recalling the products, which include eight brands of hot dog chili sauce and four flavors of Natural Balance "Eatables" dog food. FDA reports that two people in Texas and two in Indiana fell seriously ill and were hospitalized with botulism poisoning after eating the products.

-- Press release (with list of recalled products): http://www.fda.gov/bbs/topics/NEWS/2007/NEW01670.html

 

Food Recall:

 

›   Nissin Original Chow Mein Shrimp and Nissin Cup Noodles Shrimp, and other store brands 

    Reason for recall: powder in product may contain cod or lobster, potentially dangerous for those with an allergy or sensitivity to cod or lobster

http://www.fda.gov/oc/po/firmrecalls/nissin07_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

 

July 18 -- FDA Deputy Commissioner for International and Special Programs Murray M. Lumpkin, M.D., appeared before the Senate Committee on Commerce, Science and Transportation

    Subject: safety of Chinese imports

http://www.fda.gov/ola/2007/chineseimport071807.html

 

July 17 -- FDA Commissioner Andrew C. von Eschenbach, M.D., appeared before the House Subcommittee on Retirement and Aging

    Subject: "Alzheimer's Disease: FDA's Role in New Product Development"

http://www.fda.gov/ola/2007/alzheimersdisease071707.html

 

July 17 -- FDA Commissioner Andrew C. von Eschenbach, M.D., appeared before the House Subcommittee on Oversight and Investigations 

     Subject: "Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation's Food Supply?"

http://www.fda.gov/ola/2007/foodsafety071707.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

July 24 -- Oncologic Drugs Advisory Committee

    Under discussion: two pending drug approval applications

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-11496.htm

 

July 26 -- Cellular, Tissue, and Gene Therapies Advisory Committee

    Under discussion: updates on two research programs

    Location: Bethesda, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-11728.htm

 

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

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

 

 

QUESTION OF THE WEEK

 

How do biological products (biologics) differ from conventional drugs?

 

In contrast to most drugs that are chemically synthesized and their structure is known, most biologics are complex mixtures that are not easily identified or characterized. Biological products include vaccines, human tissue, blood, and blood products. Biologics, including those manufactured by biotechnology, tend to be more sensitive to heat and susceptible to microbial contamination than drugs. Therefore, it is necessary to take steps to ensure a germ-free manufacturing environment when producing biological products.

 

Biological products often represent the cutting edge of biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available.

 

For more on biologics, see http://www.fda.gov/cber/index.html.        

 

 

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