The US Food and Drug Administration (FDA) has published its long-awaited assessment of per- and polyfluoroalkyl substances ...

George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and biologics centers. The CNPV pilot program aims to expedite drug approvals by ...

One of the most controversial topics in the diagnostics space is FDA’s proposed regulation to oversee laboratory-developed tests (LDT). Most recently, FDA and the Centers for Medicare and Medicaid ...

The US Food and Drug Administration (FDA) plans to scrutinize the safety and efficacy of lab-developed tests — those designed, manufactured, and used in a single laboratory — far more thoroughly in ...

Application for OTC contraceptive highlights efforts to broaden access to medicines. FDA has been struggling for more than 10 years to devise policies and operations to facilitate the approval and ...

CALIFF, SHUREN PUSH FOR VALID ACT — Top FDA officials are becoming more pointed in their warnings that if Congress fails to take action this year on an overhaul of regulation of diagnostics and ...

The U.S. Food and Drug Administration has issued a recall of several products from Gold Star Distribution Inc., based in ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

On Friday, the US Food and Drug Administration’s Center for Tobacco Products announced steps it would take to do a better job regulating tobacco products. In December, an independent panel of experts ...

Judge finds agency ignored evidence in deeming premium cigars subject to same law as cigarettes Cigar groups, FDA will submit briefs on remedy (Reuters) - The U.S. Food and Drug Administration's ...