Tuesday, November 12, 2019

Tuesday, November 12, 2019

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

U.S. FOOD AND DRUG ADMINISTRATION: FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad

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

U.S. FOOD AND DRUG ADMINISTRATION: FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall

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

U.S. FOOD AND DRUG ADMINISTRATION: Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan

As the number of children using e-cigarettes remains at epidemic levels, our enforcement work has been one cornerstone of our efforts to protect youth from the dangers of tobacco products.

U.S. FOOD AND DRUG ADMINISTRATION: Tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety

Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety

FDA approves new doctor-certified antidepressant nasal spray

The USDA recently approved Spravato (esketamine), a new antidepressant nasal spray.

FDA Reporter