News

FDA Awards 11 Grants to Clinical Trials to Develop New Medical Products for Rare Disease Treatments

Today, the U.S. Food and Drug Administration announced it has awarded 11 new clinical trial research grants, equaling more than $25 million of funding over…

To Improve Nutrition and Reduce the Burden of Disease, FDA Issues Food Industry Guidance for Voluntarily Reducing Sodium in Processed and Packaged Foods

A cornerstone of the U.S. Food and Drug Administration’s public health mission is to reduce the burden of chronic disease through improved nutrition. As a…

Coronavirus (COVID-19) Update: October 12, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Today the FDA announced…

FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency

Today, the U.S. Food and Drug Administration announced it has authorized the marketing of three new tobacco products, marking the first set of electronic nicotine…

FDA In Brief: FDA Warns Public and Health Care Professionals Not to Use Needle-free Devices for Injection of Dermal Fillers

The following quote is attributed to Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in FDA’s Center for Devices and…

FDA Approves Innovative Treatment for Pediatric Patients with Congenital Athymia

Today, the U.S. Food and Drug Administration approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic is the…

Coronavirus (COVID-19) Update: October 8, 2021

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: On Tuesday October 5, the FDA…

FDA In Brief: FDA Warns Firms for Continuing to Market E-cigarette Products After Agency Denied Authorizations

The following quote is attributed to Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products: “The FDA is responsible for ensuring that new tobacco…

FDA Announces Signing of Domestic Mutual Reliance Agreements with California, Florida, Utah and Wisconsin

The U.S. Food and Drug Administration today announced that California, Florida, Utah and Wisconsin have entered into domestic mutual reliance agreements with the agency. These…

FDA Issues Final Order and Guidance on Surgical Staplers and Staples for Internal Use

Today, the U.S. Food and Drug Administration announced several actions related to surgical stapler and staple regulation and safety. “At the heart of our public…