FDA News -- FDA News Digest for November 13, 2007

FDA News Digest

November 13, 2007

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IN THIS WEEK'S ISSUE

» News

-- Plan Unveiled to Boost, Update Food Safety Efforts

-- FDA Strengthens Warnings for Three Anemia Drugs

-- Prescription Allergy Drug Zyrtec-D Now Available OTC

-- Silver-Coated Breathing Tube Reduces Pneumonia Risk

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

» Congressional Testimony

» Safety Alerts/Recalls

» Upcoming Public Meetings

» Consumer Health Information

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NEWS

Plan Unveiled to Boost, Update Food Safety Efforts

FDA has launched a program designed to bolster efforts to protect the nation's food supply. Called the Food Protection Plan, the program proposes using science and a risk-based approach to ensure the safety of domestic and imported foods.

› Press release: http://www.hhs.gov/news/press/2007pres/11/pr20071106a.html

› Food Protection Plan: http://www.fda.gov/oc/initiatives/advance/food/plan.html

FDA Strengthens Warnings for Three Anemia Drugs

FDA has approved revised boxed warnings and other safety-related labeling changes for erythropoiesis-stimulating agents, which are used to treat certain types of anemia. The new statements address the risks that the drugs Aranesp, Epogen, and Procrit pose to patients with cancer or with chronic kidney failure.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01740.html

Prescription Allergy Drug Zyrtec-D Now Available OTC

FDA has approved the allergy drug Zyrtec-D, previously available only by prescription, for nonprescription use in adults and children aged 12 and older. Hay fever and other allergies are the sixth leading cause of chronic disease, affecting about 50 million yearly in the United States, according to government figures.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01742.html

Silver-Coated Breathing Tube Reduces Pneumonia Risk

FDA has cleared for marketing the silver-coated Agento endotracheal tube, which reduces the risk that patients on ventilators will get pneumonia while in the hospital. Patients requiring breathing support are at risk of exposure to hospital-acquired bacteria that can build up on the breathing tube. Because silver is known to have antimicrobial properties, it can help lower pneumonia risk.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01741.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 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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CONGRESSIONAL TESTIMONY

Nov. 13 -- FDA Assistant Commissioner for Food Protection David Acheson, M.D., appeared before the House Subcommittee on Oversight and Investigations.

Subject: FDA's new Food Protection Plan

http://www.fda.gov/ola/2007/foodsafety111307.html

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

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

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SAFETY ALERTS/RECALLS