The U.S. Food and Drug Administration today released its “Strategic Plan for Regulatory Science,” calling for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy, and security.
FDA approves Zelboraf and companion diagnostic test for late-stage skin cancer
The U.S. Food and Drug Administration today approved Zelboraf (vemurafenib), a drug to treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.
Winn-Dixie Issues Voluntary Recall On ‘Winn-Dixie Choco Charm Chocolate Drink’ Due To Mislabeling And Undeclared Allergen
Winn-Dixie Stores, Inc., (NASDAQ: WINN) is voluntarily recalling “Winn-Dixie Choco Charm Chocolate Drink� from its in-store dairy departments because the product may be mislabeled and may contain the undeclared allergen of wheat. Individuals sensitive to wheat protein can suffer a moderate-acute allergic reaction.
Sold in the dairy department of Winn-Dixie and SaveRite stores, the “Winn-Dixie Choco Charm Chocolate Drink� features a 128 oz. (one gallon) clear plastic bottle with a yellow bottle cap and is marked with the UPC code 21140-29830.
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FDA seeks comment on proposed guidelines for high-quality clinical studies
The FDA today issued draft guidance to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices.
FDA proposes guidelines that clarify benefit-risk determinations for medical devices
For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.
Whole Foods Market announces recall for marinades in six Mid-Atlantic states and Washington, D.C. because of undeclared allergens
Whole Foods Market announces that it is recalling two beer-flavored marinades sold in Kentucky, Maryland, Ohio, Pennsylvania, Virginia, Princeton and Marlton, New Jersey and Washington, D.C. because of undeclared wheat and soy allergens on the label. The recalled marinades are Whole Foods Market Stout Beer Marinade, UPC code 000000305716, and Whole Foods Market Lager Beer Marinade UPC code 000000305723, both made in Landover, Maryland. The products come in 15-ounce, plastic bottles and were sold between July 3 and August 3, 2011.
FDA, state of Arkansas sign agreement to advance regulatory science
An agreement to establish a virtual Center of Excellence for Regulatory Science was signed today between the U.S. Food and Drug Administration’s National Center for Toxicological Research (NCTR) and the state of Arkansas.
FRESH FOOD CONCEPTS, INC. RECALLS LAYER DIP PRODUCTS CONTAINING GUACAMOLE BECAUSE OF POSSIBLE HEALTH RISK
Fresh Food Concepts, Inc. of Buena Park, CA is voluntarily recalling various Layer Dip products containing guacamole because the avocado has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems
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Unilever United States, Inc. Issues Allergy Alert for Mislabeled 24-Count Boxes of Popsicle® Sugar Free Orange,Cherry and Grape Flavor Due to Undeclared Milk
Unilever United States, Inc. is voluntarily recalling a limited number of mislabeled 24-count boxes of Popsicle® brand Sugar Free Orange, Cherry and Grape flavored ice pops that mistakenly contain Popsicle® brand Sugar Free Healthy Bunch® Fudgsicle® and Creamsicle® ice pops.
Miss Bonnie’s Gourmet Recalls Classic Cheddar Cheese Spread
Winchester, VA –Miss Bonnie’s Gourmet, LLC is recalling its Miss Bonnie’s Gourmet Classic Cheddar Cheese Spread distributed between 8/1/11 and 8/10/11, with a “Best By Date� of December 23, 2011 and batch code number 0116206G113 because it has the potential to be contaminated with Salmonella. The recalled product is packaged in 8 ounce glass jars and was distributed to Kroger Stores in Roanoke, Virginia; Cincinnati, Ohio; Louisville, Kentucky; and Memphis, Tennessee.
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