The U.S. Food and Drug Administration today announced it is seeking input on its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications (“apps”) that are designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or general consumer use of smartphones or tablets.
FDA approves vaccines for the 2011-2012 influenza season
The U.S. Food and Drug Administration announced today that it has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United States.
Foodborne outbreak associated with raw milk from Tucker Adkins Dairy of York S.C.
The FDA is warning consumers not to drink raw milk from Tucker Adkins Dairy of York, S.C. Three confirmed cases and five probable cases of campylobacteriosis in North Carolina are associated with raw milk from Tucker Adkins Dairy.
Willamette Valley Fruit Co. issues allergy alert on undeclared butter in 8” Apple, Cherry & Marionberry Pies
Willamette Valley Fruit Company of Salem, OR is recalling all its Apple, Cherry and Marionberry pies sold from July 1 – July 13, 2011 due to the use of butter that was undeclared on the product label. People who have allergies to dairy and/or dairy by-products run the risk of serious or life-threatening reactions if they consume this product.
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Expanded Recall: Via Xtreme Ultimate Sexual Enhancer Dietary Supplement For Men Recall
Global Wellness, LLC. Hollywood, FL is expanding its voluntary nationwide recall of Via Xtreme Ultimate Sexual Enhancer Dietary Supplement For Men to the consumer level to include lot A032111. The product was distributed throughout the U.S. Puerto Rico, Barbados, and Canada to internet and retail consumers.
Bruce Foods Corporation Recalls Food Club Red Enchilada Sauce Because Of Possible Health Risk
Bruce Foods Corporation of New Iberia, LA is recalling mislabeled cans of 10 oz Food Club Red Enchilada Sauce with code ECH 451244, Best Before Date: 5/13/2015 that could contain Green Enchilada Sauce instead of Red Enchilada Sauce.
FDA: Surgical placement of mesh to repair pelvic organ prolapse poses risks
The U.S. Food and Drug Administration today issued an updated safety communication warning health care providers and patients that surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options.
FDA seeks comment on proposed policy for diagnostic tests used with targeted drug therapies
The U.S. Food and Drug Administration today issued a new draft guidance to facilitate the development and review of companion diagnostics – tests used to help health care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft document is intended to provide companies with guidance on the agency’s policy for reviewing a companion diagnostic and the corresponding therapy.
FDA approves Boostrix to prevent tetanus, diphtheria, and pertussis in older people
The U.S. Food and Drug Administration today approved Boostrix vaccine to prevent tetanus, diphtheria, and pertussis (whooping cough) in people ages 65 and older.
Posh Bakery Issues Allergy Alert on Undeclared Eggs in Butter Mini Croissants and Chocolate Mini-Croissants
Posh Bakery of Santa Clara, CA is recalling all its Butter Mini Croissants and Chocolate Mini-Croissants due to use of an egg wash that was undeclared on the product label. People who have allergies to eggs run the risk of serious or life-threatening reactions if they consume this product.