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
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
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.
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
Advancements in the dynamic field of biotechnology are bringing about the development of innovative, new food products.
The USDA recently approved Spravato (esketamine), a new antidepressant nasal spray.
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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
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.
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
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.
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.
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.
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.
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
Long-Lasting Devices Feature Unique DX Technology and Enhanced Automation of Heart Failure Therapy
Class 2 Device Recall Gentrix Surgical Matrix Thick
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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.
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The President’s 2020 Budget includes new resources to advance the agency’s food safety program, and expand food safety monitoring
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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.