Thursday, April 9, 2020

Thursday, April 9, 2020

Latest News

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for post-partum depression

The U.S. Food and Drug Administration approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.

U.S. FOOD AND DRUG ADMINISTRATION: FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements

The U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.

U.S. FOOD AND DRUG ADMINISTRATION: FDA takes action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions

The U.S. Food and Drug Administration today posted a warning letter to Nutra Pharma Corp. for illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain, including pain associated with cancer, diabetes, shingles, fibromyalgia and other serious conditions.

BIOTRONIK: FDA Approves Industry's Smallest, Slimmest 3T Tachycardia Devices from BIOTRONIK

Long-Lasting Devices Feature Unique DX Technology and Enhanced Automation of Heart Failure Therapy

U.S. FOOD AND DRUG ADMINISTRATION: Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on advancing new tools and science for implementing agricultural water requirements for produce safety

As FDA finalizes previously proposed extensions to compliance dates for agricultural water requirements, the agency is providing an update on how it is using the additional time to ensure the feasibility of federal requirements and incorporate lessons learned from recent romaine lettuce outbreaks

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves a new generic valsartan

The U.S. Food and Drug Administration approved a new generic of Diovan (valsartan). Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure.

U.S. FOOD AND DRUG ADMINISTRATION: Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services

A federal court ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements.

U.S. FOOD AND DRUG ADMINISTRATION: Administration’s request for new FDA funding to continue to advance robust regulatory framework for oversight of e-cigarettes

Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to continue to advance robust regulatory framework for oversight of e-cigarettes, prevent youth access and initiation; and harness innovation to advance the safety of food, compounded drugs, U.S. blood supply

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

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: 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: 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, 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.

FDA Reporter