Life Sciences Regulation News

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FDA Latest News
FDA CDRH Latest News
	Consumer Information on: Therapy Cool Path Duo? Ablation Catheter, Safire BLU Duo? Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator - P110016
	The Therapy Cool Path Duo? Ablation Catheter or the Safire BLU Duo? Ablation Catheter is a steerable, deflectable, irrigated catheter (a long, thin, flexible tube) used to treat a certain kind of abnormal heart rhythm (arrhythmia2) called typical atrial..
	Summary Information for: Therapy Cool Path Duo? Ablation Catheter, Safire BLU Duo? Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator
	Labeling, Approval Order, and Summary of Safety and Effectiveness for Therapy Cool Path Duo? Ablation Catheter, Safire BLU Duo? Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator (P110016).
	Evaluation of Automatic Class III Designation (De Novo) Decision : K093295 added
	The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate.
FDA News
	FDA and industry reach agreement in principle on medical device user fees
	The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.
	FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer
	The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today?s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.
	FDA approves Kalydeco to treat rare form of cystic fibrosis
	The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.
FDA Recalls
	Healthy People Co. Issues a Voluntary Recall of Specific Lots of the Dietary Supplements Found to Contain Undeclared Drug Ingredients
	Healthy People Co. announced today that it is conducting a voluntary nationwide recall of the company?s dietary supplements sold under the brand names Healthy People Co. specific to the following Lot Numbers. Healthy People Co. is conducting a voluntary recall because FDA lab analysis has confirmed the presence of Sibutramine and Tadalafil, making these products unapproved new drugs.
	Nest Collective Voluntarily Recalls Select Revolution Foods Jammy Sammy - Strawberry Jam & Peanut Butter Snack Size Sandwich Bars Due to a Labeling Error (Undeclared Peanut on Inner Wrapper)
	Nest Collective ? announced today that it is voluntarily recalling 8150 selling units of its Jammy Sammy? - Strawberry Jam & Peanut Butter Flavor Snack Size Sandwich Bars due to a mislabeled inner wrapper. The cartons contain the best by date June 28, 2012 and are marked with the following universal product code (UPC) #89676600116 6 located on the bottom of the package.
	California Firm Recalls Prepared Sandwiches that Contain Hard-Cooked Eggs
	GH Foods CA, LLC was notified by their supplier that the eggs supplied to them were from Michael Foods, Inc, who recalled Hard-Cooked eggs due to potential contamination by Listeria monocytogenes. GH Foods CA, LLC, Sacramento, California, is therefore recalling sandwiches, associated with the affected eggs, due to potential contamination of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and individuals with weakened immune systems.