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

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 ...

On Thursday, the public had the first chance to air their grievances about the FDA’s controversial Commissioner’s National ...

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

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 (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 ...

In a bid to better deploy its boots-on-the-ground resources, the FDA is pulling back the curtain on a new pilot program, under which the regulator is leveraging “one-day inspectional assessments” to ...

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 ...