FDA News Digest for August 22, 2005

[FDA News Digest]

Title: Message

FDA News Digest

August 22, 2005

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IN THIS WEEK'S ISSUE

 

--  New Blood Test to Help Doctors Personalize Drug Treatments

--  FDA to Hold Public 'Conversations' in Three Cities

--  Report Calls Collaboration Key to Drug Breakthroughs

--  Recalls/Safety Alerts

--  Public Meetings

--  Question of the Week

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New Blood Test to Help Doctors Personalize Drug Treatments

 

FDA has cleared for marketing a new blood test that will help doctors make personalized drug treatment decisions for some patients. Called the Invader UGT1A1 Molecular Assay, the test detects variations in genes that affect how certain drugs are broken down and cleared by the body. This information allows doctors to set the right drug dosage and minimize harmful drug reactions.

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01220.html

 

FDA to Hold Public 'Conversations' in Three Cities

 

To help inform consumers about agency programs and to get public feedback, FDA is holding a series of three public meetings called "Vision 2006 -- A Conversation With the American Public."  Discussion topics include drug safety, direct-to-consumer advertising, dietary supplements, FDA's "Critical Path" initiative, and the advisory committee process. Meetings are scheduled for Sept. 13 (Miami), Nov. 2 (Boston), and Nov. 30 (Phoenix).

http://www.fda.gov/oc/initiatives/vision2006.html

 

Report Calls Collaboration Key to Drug Breakthroughs

 

Government, industry and academic researchers "can and must work together" to remove scientific hurdles and foster breakthroughs in drug development, said FDA Commissioner Lester M. Crawford, D.V.M., commenting on a report released Aug. 15 by FDA and the Association of American Medical Colleges. The report highlights ways the three groups can collaborate with the goal of getting new treatments to patients.

http://www.aamc.org/newsroom/pressrel/2005/050815.htm

 

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

 

Safety Alert

 

Gambro Dasco S.p.A is alerting the public about serious problems related to the use of its Prisma continuous renal replacement system. Several injuries and deaths have occurred due to excessive ultrafiltration (fluid being removed from the body) caused by overriding an alarm in the devices. The company says the devices remain appropriate for use when directions are followed.

http://www.fda.gov/oc/po/firmrecalls/gambro08_05.html

 

Recall

 

Casale Sun-Dried Tomatoes 2003 Crop

Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/atlantic08_05.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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PUBLIC MEETINGS

Aug. 25-26 -- General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee

Under discussion: the classification of medical maggots, medical leeches, and three devices that predate amendments to medical device law

Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12519dd08252605.html

 

Sept. 6 -- Arthritis Advisory Drugs Committee

Under discussion: pending application for rheumatoid arthritis treatment

Location: Rockville, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cder12532d090605.html

 

Sept. 8-9 -- Endocrinologic and Metabolic Drugs Advisory Committee

Under discussion: pending application for diabetes treatment

Location: Silver Spring, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cder12536dd09080905.html

 

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" can give consumers misleading information about the safety of the foods they are preparing, since the color of cooked foods varies considerably. For example, freezing and thawing may influence a meat's tendency to brown prematurely.                                                                                                          ___________________________________________________

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