The U.S. Food and Drug Administration is updating the public on the agency’s ongoing investigation surrounding the recent voluntary recalls of multiple generic angiotensin II receptor blocker (ARB) drug products used to treat high blood pressure and heart failure
Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on the FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad
Class 1 Device Recall LIFEPAK 15 Monitor/Defibrillator
Class 2 Device Recall Humeral Stem
Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on a new strategy to advance FDA’s food safety mission and modernize oversight of imported food
The U.S. Food and Drug Administration has issued a warning letter to Total Thermal Imaging Inc., of La Mesa, California, and its president and co-owner, Linda Hayes, for illegally marketing and distributing an unapproved thermography device as a sole screening device for breast cancer and other diseases.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition
Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., cautioning consumers against receiving young donor plasma infusions that are promoted as unproven treatment for varying conditions
The U.S. Food and Drug Administration permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin under the skin for children and adults with diabetes.
The U.S. Food and Drug Administration today issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States.
The U.S. Food and Drug Administration issued a warning letter to Mark Berman, M.D., of Beverly Hills, California, for illegally marketing an unapproved implantable device, the Pocket Protector, that Dr. Berman claims can prevent and treat a complication of breast implants known as capsular contracture, or tightening of scar tissue.
Products make unproven claims for treating multiple diseases and conditions
