STAT

Drug companies, patient groups urge FDA to pause commissioner’s voucher program

The listening session, held on the FDA’s White Oak Campus, featured 17 speakers representing patient groups, drug companies, ...
The Baltimore Sun

FDA announces pilot program featuring real-time clinical trial monitoring

Federal regulators have unveiled a pilot program for clinical trials that they say will reduce the time it takes to test drugs. The Food and Drug Administration program will feature real-time clinical ...
RAPS

Stakeholders offer suggestions for improving FDA’s CNPV program

During a public hearing on Thursday, the US Food and Drug Administration (FDA) received several suggestions from industry stakeholders on how to improve its Commissioner’s National Priority Voucher ...
JD Supra

New FDA Program Prioritizes Review of Certain ANDAs

On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic ...

Bill shielding federal drug program dies in state assembly

New York lawmakers won't pass a 340B drug program protection bill this session, disappointing hospitals and health centers ...
RAPS

Study: FDA’s expedited programs play increasing role in bringing novel drugs to market

Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan ...
JD Supra

Rare Disease Focus: FDA’s Trio of Cell and Gene Therapy Draft Guidances Highlight Expedited Programs, Innovative Trial Designs, and Postapproval Evidence Generation

FDA’s Center for Biologics Evaluation and Research (“CBER”) recently issued a trio of new draft guidances to assist sponsors who are developing and conducting postapproval studies of cell and gene ...

Fulcrum scraps sickle cell drug program after FDA raises cancer-risk concerns

June 1 (Reuters) - Fulcrum Therapeutics said on Monday it would stop developing its experimental sickle-cell disease drug after the U.S. Food and Drug Administration raised cancer-risk concerns, which ...
TwinCities.com

House lawmaker raises new concerns over FDA’s ultra-fast drug review program

WASHINGTON (AP) — A Democratic lawmaker raised new concerns about a Food and Drug Administration program designed to drastically shorten the review of certain drugs, including whether senior officials ...