Government ❯ Regulatory Agencies ❯ Food and Drug Administration

Drug Approval Process

Mifepristone Pediatric Drug Use Clinical Trials Psychedelic Therapies Controlled Substances New Drug Application Shortage Management Telehealth Policy Market Withdrawals Over-the-Counter Medications

FDA Launches Large Safety Study of Mifepristone

Interim results expected as soon as July could influence whether telehealth, mail delivery, or prescriber rules for the abortion pill are tightened.

Hawley Pressures FDA Chief as Anti‑Abortion Groups Demand Firing Over Reported Mifepristone Review Delay

FDA Grants Conditional Approval to Exzolt Cattle-CA1 for Screwworm and Cattle Fever Tick

FDA Adds Boxed Warning to Elevidys, Narrows Use to Ambulatory Patients 4 and Older

FDA Grants Accelerated Approval to Forzinity, First Therapy for Barth Syndrome

FDA Launches National Priority Voucher Program to Slash Drug Review Times

FDA launches AI assistant Elsa early as staff flag readiness issues

FDA Moves to Ban Ineffective Oral Phenylephrine from Cold Medicines

FDA Declines MDMA for PTSD Treatment, Requests Further Trials

FDA Rejects MDMA for PTSD Treatment, Citing Data Concerns