FDA News Digest for June 18, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

June 18, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension

    -- FDA Takes Steps to Reduce Tomato-Related Foodborne Illness

    -- 'Blitz' Finds No Widespread Problems in Human Tissue Recovery

    -- Software Tool Aims to Keep Food Facilities Safe from Attack

»  Recalls/Safety Alerts

»  Recent Speeches

»  Congressional Testimony

»  Upcoming Public Meetings

»  Question of the Week

»  New Postings on FDA.gov

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NEWS

 

FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension

FDA approved Letairis (ambrisentan) for the treatment of pulmonary arterial hypertension, a rare, life-threatening condition characterized by continuous high blood pressure within the arteries of the lungs. Letairis was granted orphan drug status by FDA because it treats a rare disease and meets other criteria. Orphan designation qualifies the drug's sponsor for a tax credit and marketing incentives.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01653.html

 

FDA Takes Steps to Reduce Tomato-Related Foodborne Illness

FDA is beginning a multi-year initiative designed to reduce tomato-related foodborne illness. Over the last decade, fresh and fresh-cut tomatoes have been linked to 12 foodborne illness outbreaks, resulting in 1,840 confirmed cases of illness. The initiative is a collaboration between FDA, state officials in Florida and Virginia, academia, and the produce industry.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01651.html

-- Tomato Safety Initiative: http://www.cfsan.fda.gov/~dms/tomsafe.html

 

'Blitz' Finds No Widespread Problems in Human Tissue Recovery

FDA's Human Tissue Task Force has released a report concluding that there are no significant industry-wide problems in the recovery of human tissues for transplantation. The agency conducted a "blitz" between October 2006 and March 2007, inspecting 153 tissue recovery companies. Though FDA observed some deviations from regulations, the agency found no inaccuracies or deficiencies that could put tissue recipients at risk.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01650.html

-- Task Force report: http://www.fda.gov/cber/tissue/httf07report.htm

 

Software Tool Aims to Keep Food Facilities Safe from Attack

FDA has released the CARVER + Shock Software Tool to help the food industry determine the vulnerability of individual food facilities to biological, chemical or radiological attack. The U.S. military originally developed the tool to identify areas vulnerable to attack. FDA and the U.S. Department of Agriculture adapted it for the food and agriculture sector.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01652.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

Toothpaste Recall:

 

›  FDA has a special page that lists the latest information on brands of toothpaste being recalled due to the presence of a poisonous chemical, diethylene glycol. 

http://www.fda.gov/oc/opacom/hottopics/toothpaste.html

 

Food Recalls:

 

›  Back to Nature Sesame Ginger Rice Thins Crackers (4 oz. size); with "Best When Used By" date of 16 May 2007.

    Reason for recall: milk component not declared on labeling

http://www.fda.gov/oc/po/firmrecalls/backtonature06_07.html

›  Expanded Recall: WholeSoy Blueberry Yogurt (6 oz. size)

    Reason for recall: dairy components not declared on labeling

http://www.fda.gov/oc/po/firmrecalls/wholesoy206_07.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

April 12 -- FDA Acting Commissioner Andrew von Eschenbach, M.D., spoke at the Food and Drug Law Institute's Annual Conference.

    Subject: "State of the FDA" address

http://www.fda.gov/oc/speeches/2007/fdli041207.html

 

To view an archive of past speeches by FDA officials, go to

http://www.fda.gov/speeches/speechli.htm.

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CONGRESSIONAL TESTIMONY

 

June  12 -- FDA Deputy Commissioner for Policy Randall Lutter, Ph.D., appeared before the House Committee on Energy and Commerce

    Subject: user fees, drug safety, and certain pediatric drugs and device legislation

http://www.fda.gov/ola/2007/userfeeact061207.html

 

To view an archive of past testimony by FDA officials, go to

http://www.fda.gov/ola/listing.html

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UPCOMING PUBLIC MEETINGS

June 27 -- Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

    Under discussion: oncology products granted pediatric exclusivity under the Best Pharmaceuticals for Children Act

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-8656.htm

 

June 27 -- Circulatory System Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for a medical device that treats atrial flutter

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-9054.htm

 

For a complete list of FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.

 

 

NEW POSTINGS ON FDA.GOV

 

›  FDA has recently posted a Web site devoted to

"Spot the Block," a campaign in partnership with

Cartoon Network to help kids understand and use

the Nutrition Facts panel on food packages.

http://www.cfsan.fda.gov/~dms/spotov.html

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