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 ...

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 ...

The US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), an investigative body charged with overseeing program performance and integrity, plans to devote part of ...

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 ...

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

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 ...

This is an archived article and the information in the article may be outdated. Please look at the time stamp on the story to see when it was last updated. WASHINGTON (AP) — The Food and Drug ...

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