FDA News Digest for December 11, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

December 11, 2006

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IN THIS WEEK'S ISSUE

 

»  News

    -- FDA Continues to Investigate Widespread E. Coli Outbreak

    -- New Proposal Would Expand Experimental Drugs Availability 

    -- Companies Warned to Stop Compounding Anesthetic Creams

    -- Latest 'Patient Safety News' Video Available Online

    -- Deputy Commissioner Gottlieb Leaving FDA for Think Tank Job

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

FDA Continues to Investigate Widespread E. Coli Outbreak

FDA is collaborating with federal, state and local officials to investigate an outbreak of E. coli O157:H7 infection in five Eastern seaboard states and Utah. Most of those affected reported eating at Taco Bell restaurants. After a preliminary analysis showed possible E. coli contamination in green onions from Taco Bell, the restaurant removed the onions from its stores nationwide.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01518.html

 

New Proposal Would Expand Experimental Drugs Availability

FDA is proposing significant regulatory changes that would make experimental drugs more widely and easily available to seriously ill patients with no other treatment options. The new rule also would clarify when it is appropriate to charge for an experimental drug.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01520.html

 

Companies Warned to Stop Compounding Anesthetic Creams

FDA is warning five companies to stop compounding and distributing topical anesthetic creams marketed for general distribution. The agency is concerned that the local anesthetics in the creams could cause adverse reactions such as seizures and irregular heartbeat. Two deaths have been connected to creams made by two of the companies.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01516.html 

 

Latest 'Patient Safety News' Video Available 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.fda.gov/psn

 

Deputy Commissioner Gottlieb Leaving FDA for Think Tank Job

Scott Gottlieb, M.D., FDA deputy commissioner for medical and scientific affairs, will leave the agency Jan. 16 for a position in the American Enterprise Institute, a Washington-based think tank. While at FDA, Gottlieb has worked to improve the advisory committee process and the dissemination of risk information to the public.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01519.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

Food Recalls:

 

Certain lots of Lucia brand and HDC brand cantaloupes

    Reason for recall: possible Salmonella contamination

-- Lucia cantaloupes: http://www.fda.gov/oc/po/firmrecalls/farmersbest12_01.html

-- HDC cantaloupes: http://www.fda.gov/oc/po/firmrecalls/Vandervoet12_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

Dec. 5 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke before Windhover's FDA/CMS Summit

    Subject: health policy

http://www.fda.gov/oc/speeches/2006/windhover1205.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. 13 -- Psychopharmacologic Drugs Advisory Committee

    Under discussion: Suicidality data from clinical trial of adult antidepressants

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-19248.htm

 

Dec. 14 -- Blood Products Advisory Committee

    Under discussion: an emergency research study of bovine polymerized hemoglobin

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-20265.htm

 

Dec. 18 -- Public hearing to solicit comments on electronic submission of premarket material and other regulatory information

    Location: Rockville, Md.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01510.html

 

Jan. 9 -- Public Workshop on Marketed Unapproved Drugs

    Under discussion: how businesses can obtain FDA approval to legally market currently unapproved drug products

    Location: Rockville, Md.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01500.html

-- Federal Register notice: http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-17959.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

 

What is a stent?

A stent is a tiny, lattice-shaped, metal tube that is inserted permanently into an artery. Drug-eluting stents are stents that contain drugs to potentially reduce the chance that arteries will become blocked again.

 

Stents are used to hold open arteries that have become too narrow due to atherosclerosis, a condition in which plaque builds up on the inner walls of arteries, the blood vessels that carry oxygen-rich blood throughout the body. As artery walls thicken, the pathway for blood narrows. This can slow or block blood flow.

 

Stents act as a scaffold, remaining in place permanently to help keep arteries open so blood can flow.

 

For more on stents, see http://www.fda.gov/hearthealth/treatments/medicaldevices/stent.html.

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