FDA News Digest for July 10, 2006

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FDA News Digest     

July 10, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- Latest 'Patient Safety News' Video Available Free Online

    -- Web Pages Give Background on Recently Approved Devices 

»  Recalls/Safety Alerts

»  Recent Speeches

»  Upcoming Public Meetings

»  Question of the Week

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NEWS
 

Latest 'Patient Safety News' Video Available Free Online

FDA has posted the latest edition of "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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm

 

Web Pages Give Background on Recently Approved Devices
FDA's Center for Devices and Radiological Health has posted online consumer information on three recently approved medical devices:
    *  Stelkast Surpass Acetabular System
    Intended use: a surgically implanted hip replacement
    *  DexCom STS Continuous Glucose Monitoring System
    Intended use: to allow diabetics to track blood glucose levels every 5 minutes, up to 72 hours
   *  Zilver Vascular Stent
    Intended use: to treat narrowing of the arteries that supply blood to the legs and pelvis
 
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

Device Recall:
 
MRL Inc.'s PIC50 External Monitor/Defibrillator (made between February 2002 and October 2004)
    Reason for recall: potential for malfunction

http://www.fda.gov/oc/po/firmrecalls/MRL07_06.html

 
Food Recall: 
 
Certain lots of Publix Chocolate Chip Cookie Dough; 18-oz. size
    Reason for recall: undeclared pecans

http://www.fda.gov/oc/po/firmrecalls/publix06_06.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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RECENT SPEECHES

 

July 10 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke at the 2006 Conference on Adaptive Trial Design.

    Subject: the future of new drug development

http://www.fda.gov/oc/speeches/2006/trialdesign0710.html

 

June 30 -- FDA Acting Commissioner Andrew C. von Eschenbach, M.D., spoke at the FDA Centennial Celebration.

    Subject: the past and future of FDA

http://www.fda.gov/oc/speeches/2006/centennial0630.html

 

To view an archive of past speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm.

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UPCOMING PUBLIC MEETINGS

July 12 -- FDA Workshop on Testing for Malarial Infections in Blood Donors

    Under discussion: current information that might support donor testing for malaria as part of screening

    Location: Bethesda, Md.

http://www.fda.gov/cber/meetings/malaria071206.htm

 

July 12-13 -- The Essentials of Food and Drug Administration Device Regulations: A Primer for Manufacturers and Suppliers

    Under discussion: FDA device regulations, especially for small businesses and their suppliers

    Location: Fremont, Calif.

http://www.fda.gov/OHRMS/DOCKETS/98fr/06-5570.htm

 

July 13-14 -- Blood Products Advisory Committee

    Under discussion: malarial infections in blood donors; West Nile virus

    Location: Gaithersburg, Md.

http://www.fda.gov/cber/advisory/bp/bp0706.htm 

 

July 14 -- Ophthalmic Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for an implantable miniature telescope to treat certain eye disorders

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-9601.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

 

Why is it important to use a cooking thermometer?

One of the critical factors in fighting foodborne illness is temperature. Bacteria grow slowly at low temperatures and multiply rapidly at mid-range temperatures. To be safe, a product must be cooked to an internal temperature high enough to destroy harmful bacteria.

 

Using a meat thermometer is a reliable way to ensure that food has reached the proper temperature. However, to be effective, thermometers must be used properly and calibrated correctly. If the thermometer is inserted incorrectly, or placed in the wrong area, the reading may not accurately reflect the internal temperature of the product. In general, the thermometer should be placed in the thickest part of the food, away from bone, fat or gristle. Read the manufacturer's instructions on how to check the accuracy of the thermometer.

 

According to the U.S. Department of Agriculture, measuring temperature is the only way to gauge whether food is sufficiently cooked. USDA research reveals that the "color test" is a misleading way to gauge the safety of foods being prepared, since the color of cooked foods varies considerably. For example, freezing and thawing may influence a meat's tendency to brown prematurely.

 

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

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