Government ❯ Regulatory Agencies ❯ Food and Drug Administration

Drug Approval Process

Priority Review Pediatric Drug Use Clinical Trials Psychedelic Therapies Controlled Substances New Drug Application Shortage Management Market Withdrawals Over-the-Counter Medications Mifepristone Clinical Protocol Reviews Conditional Drug Approval Safety Regulations Patient Advocacy Mifepristone Review Patient Safety

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

The FDA describes an evidence‑driven study now in a data‑gathering phase with no projected timeline.

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 AI assistant Elsa early as staff flag readiness issues