Food and Drug Administration

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA took additional actions as part of the agency’s work to ensure any electronic nicotine delivery system (ENDS) products available for sale have demonstrated that marketing of the products is appropriate for the protection of the public health.

FDA and representatives from the medical device industry have reached an agreement on proposed recommendations for the fifth reauthorization of the medical device user fee program.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

On Wed., April 6, FDA will hold a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss considerations for future COVID-19 vaccine booster doses and the strain selection process to address current and emerging variants during the Fall season 2022.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

The U.S. Food and Drug Administration in collaboration with the Reagan-Udall Foundation for the FDA will hold a virtual public workshop to discuss critical questions around access to naloxone, a drug used to reverse opioid overdoses.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

The FDA approved the first generic of Symbicort for the treatment of asthma and for the maintenance treatment of patients with COPD.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

The FDA issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s recall of certain Philips Respironics ventilators, continuous positive airway pressure and bilevel positive airway pressure machines.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review; Agency’s First Enforcement Discretion Decision for an IGA in an Animal for Food Use

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA issues guidance to help companies prepare to quickly and effectively remove violative products from the market and limit the public’s exposure to risk.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

The FDA approved a drug to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. The approval will provide a treatment option for a wider range of patients with heart failure.

FDA authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse.