FDA News Digest for October 16, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

October 16, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- Positive E. Coli Results Found on Ranch Implicated in Spinach Outbreak

    -- Lung Cancer Treatment Adds Avastin to Chemotherapy Regimen

    -- Dementia Drug Approved for Expanded Use in Alzheimer's Patients

»  Recalls/Safety Alerts

»  Recent Speeches

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

Positive E. Coli Results Found on Ranch Implicated in Spinach Outbreak

Investigators have found evidence of dangerous bacterial strain E. coli O157:H7 in samples of cattle feces on one of the California ranches implicated in the recent spinach-related disease outbreak. FDA calls the results "a significant finding." Further tests at all four ranches implicated in the outbreak -- which are not currently being used to grow fresh produce -- are in progress.  

-- FDA statement: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01489.html

-- More information: http://www.fda.gov/oc/opacom/hottopics/spinach.html

-- Questions and answers (English): http://www.cfsan.fda.gov/~dms/spinacqa.html

-- Questions and answers (Spanish): http://www.cfsan.fda.gov/~dms/sspinaqa.html 

 

Lung Cancer Treatment Includes Avastin in Chemotherapy Regimen

FDA has approved the addition of colon cancer drug Avastin to the standard chemotherapy treatment for non-small cell lung cancer, which accounts for about 75 percent of new lung cancer cases. FDA based the approval on improvement in survival time when Avastin is added to the standard regimen. The American Cancer Society predicts that about 174,400 new lung cancer cases will be diagnosed this year.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01488.html

 

Dementia Drug Approved for Expanded Use in Alzheimer's Patients

FDA has approved Aricept to treat severe dementia in patients with Alzheimer's disease. The agency approved the drug in 1996 to treat mild-to-moderate dementia, making it now the first drug to treat all severity levels of Alzheimer's. The disease affects about 4.5 million Americans.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01491.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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RECALLS/SAFETY ALERTS

Safety Alert:

 

FDA is warning consumers not to use counterfeit blood glucose test strips being sold with various models of One Touch brand blood glucose monitors. The counterfeit strips -- certain lot numbers of One Touch Basic Profile and One Touch Ultra -- could give incorrect readings, potentially leading to serious injury or death.

For lot numbers and more information, see http://www.fda.gov/bbs/topics/NEWS/2006/NEW01490.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

Sept. 26 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke at the FDA Center for Devices and Radiological Health Workshop on Risk Communication.

    Subject: managing scientific and medical information

http://www.fda.gov/oc/speeches/2006/CDRH0926.html

 

Sept. 25 -- FDA Acting Commissioner Andrew von Eschenbach, M.D., spoke before the Pan American Health Organization.

    Subject: combating disease globally

http://www.fda.gov/oc/speeches/2006/paho0925.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

Oct. 18-19 -- Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science

    Under discussion: possible tamoxifen labeling changes; evaluation of transporter-based drug interactions

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-14296.htm

 

Oct. 19-20 -- Antiviral Drugs Advisory Committee

    Under discussion: clinical trials for hepatitis C treatments

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-12890.htm

 

Oct. 31 -- Neurological Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for approval of a device to treat depression

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/06-8114.htm

 

Nov. 6-7 -- "A Critical Path Approach to Rapid Diagnostics Development and Infectious Disease Treatment"

    Under discussion: shortening the critical path in new product development

    Location: Washington, D.C.

http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=11361&eventType=Meeting

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 should I use a food thermometer?

A food thermometer can help prevent foodborne illness by measuring the internal temperature of meat, poultry, and egg dishes. Using a food thermometer not only can keep you and your family safe from harmful food bacteria, but it also helps avoid overcooking, providing a safe and flavorful meal.

 

To learn more, go to www.foodsafety.gov/~fsg/fsthermy.html.  

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