FDA News Digest for June 11, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

June 11, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- Web Pages Give Background on Newly Approved Medical Devices

    -- 'FDA Patient Safety News' Video Available Online and as Podcast

»  Recalls/Safety Alerts

»  Congressional Testimony

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

Web Pages Give Background on Newly Approved Medical Devices

FDA's Center for Devices and Radiological Health has posted online consumer information for three recently approved products:

    »  C-flex intraocular lens

     Intended use: to restore vision and replace the eye's natural lens after it is removed during cataract surgery

    More information: http://www.fda.gov/cdrh/mda/docs/P060011.html 

    »  Mynx Vascular Closure System

    Intended use: to seal a puncture site in the femoral artery and to stop bleeding after a cardiac catheterization procedure

    More information: http://www.fda.gov/cdrh/mda/docs/P040044S001.html

    »  Immulite/Immulite 1000 and Immulite 2000 Free PSA

    Intended use: to help diagnose prostate cancer in men aged 50 and older

    More information: http://www.fda.gov/cdrh/mda/docs/P060005.html

 

'FDA Patient Safety News' Video Available Online and as Podcast

FDA has posted the latest edition of "FDA Patient Safety News," a free Web-based video news program. Aimed primarily at health professionals, the program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls.

-- To view video or text version: http://www.fda.gov/psn

-- To access Podcast: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/podcast.cfm

 

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

Food Recalls:

 

›  Ferrari Chocolate

    Reason for recall: peanuts not declared on labeling and presence of aflatoxins (byproducts of certain fungi)

http://www.fda.gov/oc/po/firmrecalls/tristar06_07.html

›  Certain lots of Toby's Lite Sour Creme (8 oz. size) and Toby's Toasted Sesame Dressing (12 oz. size)

    Reason for recall: possible Salmonella contamination

http://www.fda.gov/oc/po/firmrecalls/toby06_07.html

›   WholeSoy Blueberry Yogurt (6 oz. size)

    Reason for recall: dairy components not declared on labeling

http://www.fda.gov/oc/po/firmrecalls/wholesoy06_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

 

June 6 -- FDA Commissioner Andrew C. von Eschenbach, M.D., appeared before the House Committee on Oversight and Government Reform

    Subject: Type 2 diabetes drug Avandia

http://www.fda.gov/ola/2007/Avandia060607.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

June 12-13 -- Public hearing to obtain feedback on FDA's Medication Guide program

    Location: Washington, D.C.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01606.html

 

June 13 -- Endocrinologic and Metabolic Drugs Advisory Committee

    Under discussion: pending application for a drug treatment for obesity

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-5506.htm

 

June 14 -- FDA Science Board

    Under discussion: food protection, melamine, antibiotic resistance

    Location: Gaithersburg, Md.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01649.html

 

June 27 -- Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

    Under discussion: oncology products granted pediatric exclusivity under the Best Pharmaceuticals for Children Act

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-8656.htm

 

June 27 -- Circulatory System Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for a medical device that treats atrial flutter

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-9054.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

 

Who performs liposuction and where is it performed?

Many liposuction surgeries -- procedures intended to remove fat deposits and shape the body -- are performed by plastic surgeons or dermatologists. Any licensed physician may perform liposuction. While professional societies may recommend training before performing liposuction surgery, no standardized training is required. As a result, there will be differences in experience and training in physicians performing liposuction.

 

You can ask your physician to tell you whether he or she has had specialized training to do liposuction or has successfully done liposuction before. But remember, even the best screened patients under the care of the best trained and experienced physicians may experience complications as a result of liposuction.

 

Liposuction may be performed in a doctor's office, surgical center, or hospital. Because liposuction is a surgical procedure, it is important that it be performed in a clean environment. Emergencies may arise during any surgery and access to emergency medical equipment or a nearby hospital emergency room is important.  

 

For more information on liposuction, see http://www.fda.gov/cdrh/liposuction/.

 

 

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