FDA News Digest for December 5, 2005

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

Title: Message

FDA News Digest

December 5, 2005

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IN THIS WEEK'S ISSUE

 

--  Test Screens for West Nile Virus in Donors of Blood, Other Products

--  OTC Eye Drop Maker Shuts Down Due to Manufacturing Problems

--  Latest FDA Consumer Magazine Available Online

--  Recent Speeches

--  Upcoming Public Meetings

--  Question of the Week

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Test Screens for West Nile Virus in Donors of Blood, Other Products

 

FDA has approved the Procleix WNV Assay, the first blood test to screen donors of blood, organs, cells, and tissues for the West Nile virus. FDA reports that 30 people have likely acquired West Nile from blood transfusions, nine of whom died. The new test will help protect blood recipients against the virus.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01266.html

-- West Nile virus information: http://www.fda.gov/oc/opacom/hottopics/westnile.html

 

OTC Eye Drop Maker Shuts Down Due to Manufacturing Problems

 

California-based MBI Distributing Inc. has agreed to stop making and distributing its over-the-counter eye drops and pain-relieving drugs until it corrects poor manufacturing conditions and other violations. MBI's product line includes eye drops sold under the names Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and Can-C.

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01265.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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Latest FDA Consumer Magazine Available Online

 

The November-December 2005 issue of FDA Consumer is a special issue devoted to genomics, an emerging science that the magazine calls "the future of medicine." Articles in that issue are on these topics:

 

--  The human genome map -- It has set the stage for advances in the diagnosis, treatment, and prevention of disease.

--  Personalized medicine -- Your 35,000 genes may predict how you will respond to drugs.

--  Proteomics -- Find out how "mini-machines" may help treat diseases.

--  An "-omics" glossary -- Important terms and concepts are defined.

--  Metabolomics -- Body fluids can give clues about individual reactions to drugs.

--  Genomics and medical devices -- New diagnostic devices are helping doctors better understand certain diseases.   

--  Nanotechnology -- Researchers are working at scales of 1/1,000th the width of a human hair to develop new medical treatments.

 

The issue is online at http://www.fda.gov/fdac/605_toc.html.

 

Subscribe to the print version of FDA Consumer:  http://www.fda.gov/fdac/orderform/fdap.html

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RECENT SPEECHES

Nov. 29 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke before the Pharmaceutical Research and Manufacturers of America (PhRMA) Scientific Regulatory Meeting.

Subject: drug development and regulation

http://www.fda.gov/oc/speeches/2005/phrma1129.html

 

Nov. 30 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke before the Grocery Manufacturers of America Annual Meeting

Subject: diet and disease relationship

http://www.fda.gov/oc/speeches/2005/gma1130.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

Dec. 7-8 -- Hearing to obtain public input on the agency's current risk communications and outreach strategies on drug safety, which include patient information sheets, press releases, public health advisories, and other tools.

Location: Washington, D.C.

http://www.fda.gov/bbs/topics/answers/2005/ans01367.html

 

Dec. 7-8 -- Industry Exchange Workshop on FDA's Statutory and Regulatory Requirements for Clinical Trials

Location: Cincinnati, Ohio

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-18654.htm

 

Dec. 15 -- Joint FDA/USDA meeting to discuss a consistent regulatory approach concerning the jurisdiction over certain products containing meat or poultry.

Location: Rosemont, Ill.

http://www.fda.gov/bbs/topics/news/2005/NEW01255.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

 

Do wireless (cell) phones pose a health hazard?

 

The available scientific evidence does not show that any health problems are associated with using cell phones. There is no proof, however, that these phones are absolutely safe. Cell phones emit low levels of radiofrequency energy (RF) in the microwave range while being used. They also emit very low levels of RF when in the standby mode.

 

Whereas high levels of RF can produce health effects (by heating tissue), exposure to low-level RF that does not produce heating effects causes no known adverse health effects. Many studies of low-level RF exposures have not found any biological effects. Some studies have suggested that some biological effects may occur, but such findings have not been confirmed by additional research. In some cases, other researchers have had difficulty reproducing those studies, or determining the reasons for inconsistent results.

 

For more on cell phones, go to http://www.fda.gov/cellphones/

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