Life Sciences Regulation News

FDA Latest News
	FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products
	The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium.
	Health and Diet Survey: Dietary Guidelines Supplement - Report of Findings (2004 and 2005)
	The Health and Diet Survey: Dietary Guidelines Supplement tracks national change of Americans' attitudes, awareness, knowledge, and behavior regarding various elements of nutrition and physical activity.
	Withdrawal of Guidance: Guidance for Industry on the FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues
	FDA is announcing the withdrawal of a guidance document entitled "FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues"
FDA CDRH Latest News
	Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Slides
	On April 24, 2008, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by VisionCare Technologies, Inc., for an implantable miniature telescope (IMT?). The IMT?, a visual prosthetic device, is in...
	PMA Final Decisions for April 2008
	These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for April 2008.
	Summary Information for: Thoratec HeartMate II® Left Ventricular Assist System (LVAS)
	PDF format only. Topics: Ventricular Assist Device
FDA News
	FDA Approves New Formulation of Coagulation Therapy
	he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years.
	FDA Approves First Generic Ropinirole
	The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.
	FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products
	The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium.
FDA Recalls
	Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6)
	Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution.
	Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled
	The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007.
	Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2)
	Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash.