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Life Sciences Regulation News

FDA Latest News
What's New in Food
Food safety and nutrition announcements, and newly posted documents on the FDA/Foods website.
FDA CDRH Latest News
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements
FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.
Class I Medical Device Recall: Baylis Medical Company Inc., Torflex Transseptal Guiding Sheath
These sheaths are used to pass heart catheters from the right to the left side of the heart by crossing the middle heart wall (septum).
Safety Investigation of Counterfeit Polypropylene Surgical Mesh: Initial Communication
FDA's and Bard's investigations show that the counterfeit product is labeled with the following product codes, sizes and lots of Bard Flat Mesh. To date four product sizes have been identified...
FDA News
FDA Announces New Boxed Warning on Plavix
The U.S. Food and Drug Administration today added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form.
FDA Task Force Seeks Public Comments on Increasing Transparency with Regulated Industry
As part of the final phase of its transparency initiative, the U.S. Food and Drug Administration is seeking comment from the public and other interested stakeholders on how the agency can increase transparency in its interactions with regulated industry.
FDA Issues Warning on Counterfeit Surgical Mesh
The U.S. Food and Drug Administration today warned health care providers and consumers about counterfeit surgical mesh being distributed in the United States under the C. R. Bard/Davol brand name. Surgical mesh products are used to reinforce soft tissue where weakness exists.
FDA Recalls
McCormick Recall Due to Possible Health Risk from HVP Ingredient Expands to Include Additional "Best By" Dates
McCormick & Company, Incorporated (NYSE:MKC) is expanding a March 5, 2010 recall to include additional "Best By" dates of products manufactured with HVP (hydrolyzed vegetable protein) supplied by Basic Food Flavors of Las Vegas, Nevada, because the ingredient has the potential to be contaminated with Salmonella. "Consumption of products containing Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems...
Austinuts Of Dallas, Inc. Announces Voluntary Recall of Honey Mustard Pretzels
Austinuts of Dallas, Inc. has issued a voluntary recall for Honey Mustard Pretzels, Lot number 61150/0280 because the product may be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Orval Kent Food Company, Inc. Voluntarily Recalls Culinary Circle Dips Due to Possible Health Risk
Orval Kent announced today that it is voluntarily recalling multiple dips as a precautionary measure because the product may be contaminated with Salmonella. The Orval Kent dips are being recalled because they contain HVP (hydrolyzed vegetable protein) manufactured, distributed and recalled by Basic Food Flavors, Inc., Las Vegas, NV.
 
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