In a year that saw advisory committees placed under a particularly bright microscope at the FDA, the agency held fewer ...

Pitts, a former FDA associate commissioner, was the agency’s senior official in charge of advisory committees. During my time at the Food and Drug Administration, I was the senior official in charge ...

U.S. Food and Drug Administration (FDA) advisory committees play a key role in evaluating the efficacy and safety of new drugs. They include open public hearing sessions, whereby patients, clinicians, ...

The recent controversies about the safety of antidepressants during pregnancy and hormone therapy for menopause were heightened by how decisions are being made. Earlier this month, HHS officials ...

FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions from ...

Overall, 82%, 11%, and 7% of speakers supported drug approval, opposed approval, and were neutral, respectively. (HealthDay News) — Most speakers attending US Food and Drug Administration (FDA) Human ...

Before Exelexis’ Cabometyx can pass muster with the FDA in its hopeful neuroendocrine tumors indication next April, it will have to first face the agency’s Oncologic Drugs Advisory Committee (ODAC) in ...

PRINCETON, N.J.--(BUSINESS WIRE)--UroGen (NASDAQ: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced ...

Gattex (teduglutide), a drug for the treatment of adult short bowel syndrome, has received a recommendation for approval from the FDA’s Gastrointestinal Drugs Advisory Committee, according to a news ...

The researchers found that 48% of speakers are patients and family members, 99% of whom support drug approval. HealthDay News — Most speakers attending US Food and Drug Administration (FDA) Human Drug ...