JD Supra

The Return of CBER Director Prasad, FDA Announces New Chief Counsel, and FDA Budget Watch

In last week′s Pulse, we discussed the July 29 resignation of the Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad, M.D., M.P.H., from FDA, following mounting political ...
KTLA

FDA CBER Director Dr. Vinay Prasad to Keynote NORD's Inaugural Rare Disease Scientific Symposium, Convening Top Researchers, Industry Leaders, and Federal Regulators

WASHINGTON, May 23, 2025 /PRNewswire/ -- The National Organization for Rare Disorders (NORD®) will convene leading voices in science, industry, and regulation at its inaugural Rare Disease Scientific ...
FiercePharma

FDA's Prasad tells staffers agency plans to get tougher on vaccine regulation, blames child deaths on COVID shots

The FDA is planning to tighten its regulations for vaccines, according to an internal email sent by Vinay Prasad, M.D., who heads up the agency’s Center for Biologics Evaluation and Research (CBER).
FierceBiotech

UPDATE: Analyst questions impact of FDA's rare disease pathway proposal

The FDA has outlined a new review process for drugs and biologics designed to treat ultrarare genetic diseases that would allow a single-arm trial, plus other supportive data, to serve as pivotal ...