The Food and Drug Administration's controversial vaccine chief, Dr. Vinay Prasad, is once again leaving the agency.

The Food and Drug Administration’s vaccine chief, Dr. Vinay Prasad, will depart the agency next month, an FDA spokesperson ...

WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) said it received guidance from the U.S. Food and Drug Administration ...

In an interview, C. Ola Landgren, MD, PhD, delved into the details of the FDA's draft guidance on using MRD as a basis for ...

FDA draft guidance could speed approval of individualized genome editing and RNA therapies for rare diseases. Read more here.

The FDA is planning to only ask for one pivotal clinical trial instead of the long standard of two trials for drug approval. The present FDA commissioner believes it carries the same statistical power ...

The council decided 5-2 to at least entertain the idea. Long Beach and Costa Mesa have regulations on self-checkout operations in place.

In a highly unusual move for a normally buttoned-up regulatory agency, a senior official with the US Food and Drug Administration held a call with reporters Thursday to defend the agency’s recent ...

Vanda Pharmaceuticals’ seven-year ambition to score a coveted label expansion for sleep drug Hetlioz has taken an unusual turn, with the FDA acquiescing to a formal hearing on the matter. | The ...

AICA currently supports auditing against 21 CFR Parts 11, 211, and 600, each mapped at the section and subsection levels.

Ahead of Rare Disease Day, Abigail Beaney spoke with Robert Barrie and Frankie Fattorini on recent developments in the rare disease space.

Louisiana Attorney General Liz Murrill has filed a lawsuit against the FDA to challenge the regulation of abortion pills, seeking stricter medical oversight and in-person dispensing for the ...