FDA News Digest for May 5, 2008

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA News Digest for May 5, 2008

FDA News Digest

May 5, 2008

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IN THIS WEEK'S ISSUE

 

»  News

    -- FDA Clears Coronary Artery Plaque Imaging Device

    -- Amitiza Approved for Irritable Bowel Syndrome with Constipation

    -- Agency Plans to Fill More Than 1,300 Jobs in Major Hiring Initiative

    -- 'FDA Patient Safety News' Video, Podcast Available

»  Safety Alerts/Recalls

»  Upcoming Public Meetings

»  Consumer Health Information

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NEWS

 

FDA Clears Coronary Artery Plaque Imaging Device

FDA has cleared for marketing the InfraReDx LipiScan NIR Catheter Imaging System, a device doctors can use to see inside blood vessels to assess the fat content of plaque that builds up on coronary artery walls. Plaque is made up of cholesterol-rich fat, calcium, and other substances found in blood. As plaque accumulates on the artery wall, it reduces blood flow to the heart muscle and increases the risk of blood clots, which can lead to a heart attack. The new device can help doctors identify plaques that may be of particular concern.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01827.html

 

Amitiza Approved for Irritable Bowel Syndrome with Constipation

FDA has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in women aged 18 and older. There is currently no prescription drug therapy for IBS-C. With this approval, Amitiza becomes the only FDA-approved medical treatment for IBS-C available in the United States. Irritable bowel syndrome is a disorder characterized by cramping, abdominal pain, bloating, constipation, and diarrhea. It affects at least twice as many women as men. 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01828.html 

 

Agency Plans to Fill More Than 1,300 Jobs in Major Hiring Initiative

Biologists, chemists, medical officers, mathematical statisticians and investigators are among the experts in demand as FDA begins a multi-year hiring initiative. The agency is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and effectiveness of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation. In fiscal year 2008 alone, the agency is looking to fill more than 600 new positions and to backfill over 700 others to implement the FDA Amendments Act of 2007, the Food Protection Plan, and the Import Safety Action Plan. That's nearly triple the number of people hired between 2005 and 2007.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01829.html

 

'FDA Patient Safety News' Video, Podcast Available

FDA has posted the latest edition of "FDA 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.

-- To view video or text version: http://www.fda.gov/psn

-- To access Podcast: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/podcast.cfm

 

To view an archive of recent 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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SAFETY ALERTS/RECALLS

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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UPCOMING PUBLIC MEETINGS

 

For a complete list of upcoming meetings, seminars, and other public events sponsored

or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html.

 

 

CONSUMER HEALTH INFORMATION

 

This week's spotlight consumer updates are:

 

› Combating Antibiotic Resistance

http://www.fda.gov/consumer/updates/antibiotics050108.html   

› Strengthening Beef Safety

http://www.fda.gov/consumer/updates/beefsafety042508.html

 

To receive all consumer updates by e-mail, go to http://www.fda.gov/consumer/consumerenews.html.

For the latest in consumer health news from FDA, visit http://www.fda.gov/consumer/default.htm.

 

 

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