Fierce Biotech

Lawmakers probe FDA's new priority voucher program, cite corruption and rushed review concerns

As the FDA's Commissioner's National Priority Voucher (CNPV) program has picked up steam, with 15 companies now having ...
Fierce Biotech

FDA says it's hiring more than 1,000 new staffers, launches new comms program for review process

The FDA says it is hiring more than 1,000 new employees and rolling out a pilot communication program in efforts to speed up the review of new drugs. | The FDA is hiring more than 1,000 new employees ...
Becker's Hospital Review

5 FDA moves reshaping US drug policy

FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.
Becker's Hospital Review

Lawmakers raise concerns over FDA drug voucher program

Lawmakers raise concerns over FDA drug voucher program citing safety risks, transparency issues, and legal questions in a Nov. 20 letter to agency leaders.
BioSpace

Pazdur Questions Safety, Legality of FDA’s Expedited Drug Approval Programs

Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several ...
JD Supra

FDA Expands Early Alert Program to All Medical Devices

On September 29, 2025, the U.S. Food and Drug Administration (FDA) announced the expansion of its Early Alert program to include all medical devices. This expansion builds on a pilot program that ...
WCVB Channel 5 Boston

FDA to offer faster drug reviews to companies promoting 'national priorities'

U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting “the health interests of Americans,” under a new initiative announced Tuesday. Food ...
Neurology Advisor

Fourth FDA Drug Chief This Year Steps Down, Raising Stability Concerns

The FDA is facing even more leadership changes as drug regulator Dr Richard Pazdur prepares to retire at the end of the month.