Thursday, September 19, 2019

Thursday, September 19, 2019

Latest News

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 approves new at home smartphone urinalysis test kit

The FDA recently approved a home urinalysis test kit comparable to clinical testing.

Heartland Institute's Hudgins says U.S. could learn from Japanese drug-approval model

Heartland Institute's Hudgins says U.S. could learn from Japanese drug-approval model

Israeli device for treating Alzheimer's moves slowly through FDA-approval process for use in U.S.

An Israeli company is still working to get a medical device it says treats and potentially cures Alzheimer’s disease to be approved for use in the United States.

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: 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.

FDA Commissioner Scott Gottlieb steps down; stakeholders concerned about future

Food and Drug Administration (FDA) commissioner Scott Gottlieb announced his planned resignation last week and will step down next month, leaving stakeholders concerned about the future.

Temporary FDA director replaces Scott Gottlieb

WIth a temporary replacement named to the top seat of the Food and Drug Administration today, pharmaceutical industry leaders expressed relief, while others puzzled at the unexpected departure.

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: 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

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: 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.

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.

FDA Reporter