Tuesday, February 18, 2020

Tuesday, February 18, 2020

Latest News

U.S. FOOD AND DRUG ADMINISTRATION: FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants

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.

U.S. FOOD AND DRUG ADMINISTRATION: FDA advances new proposed regulation to make sure that sunscreens are safe and effective

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.

U.S. FOOD AND DRUG ADMINISTRATION: FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

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.

U.S. FOOD AND DRUG ADMINISTRATION: Cautioning consumers against receiving young donor plasma infusions that are promoted as unproven treatment for varying conditions

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

U.S. FOOD AND DRUG ADMINISTRATION: New policy to improve access and foster price competition for drugs that face inadequate generic competition

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

U.S. FOOD AND DRUG ADMINISTRATION: FDA issues warning letter to clinic illegally marketing unapproved thermography device, warns consumers to avoid using thermography devices to detect breast cancer

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.

U.S. FOOD AND DRUG ADMINISTRATION: New strategy to advance FDA’s food safety mission and modernize oversight of imported food

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

U.S. FOOD AND DRUG ADMINISTRATION: FDA’s modern approach to advanced pharmaceutical manufacturing

Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s modern approach to advanced pharmaceutical manufacturing

U.S. FOOD AND DRUG ADMINISTRATION: FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health emergencies

The U.S. Food and Drug Administration, Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) announced the launch of the Tri-Agency Task Force for Emergency Diagnostics.

U.S. FOOD AND DRUG ADMINISTRATION: The agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse

Statement from FDA Commissioner Scott Gottlieb, M.D. on the agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse

FDA Reporter