FDA

FDA Issues Landmark Proposal to Improve Access to Hearing Aid Technology for Millions of Americans

Today, the U.S. Food and Drug Administration issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for…

FDA Permits Marketing of New Oral Tobacco Products through Premarket Tobacco Product Application Pathway

Today, the U.S. Food and Drug Administration announced it has authorized the marketing of four new oral tobacco products manufactured by U.S. Smokeless Tobacco Company…

FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira

The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is…

Coronavirus (COVID-19) Update: 10/15/21

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: On Oct. 12, the FDA posted…

FDA to Hold Advisory Committee Meeting to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment

Today, the U.S. Food and Drug Administration is announcing an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss Merck and Ridgeback’s request…

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 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…