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

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 ...

But from the get-go, the program has been plagued by confusion. Critics say the listed priorities are overly vague, the ...

Two members of Congress launched an investigation into FDA Commissioner Marty Makary, MD, MPH, and his use of "priority vouchers" for expedited drug approvals, suggesting that the voucher program ...

Successful End-of-Phase 2 meeting with FDA agreeing on key elements of the proposed Phase 3 design, including study population, dosing regimen, and treatment duration – – FDA agrees on UMSARS Part I ...

WASHINGTON (AP) — The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to ...

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 ...

WASHINGTON — The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Trump’s administration is causing alarm across the agency, stoking ...