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 Safety Regulations

3 ARTICLES

2mo ago

FDA Launches National Priority Voucher Program to Slash Drug Review Times

The initiative is being rolled out with broad commissioner discretion over voucher awards, raising questions about oversight of its fast-track approvals.

8 ARTICLES

2mo ago

FDA Rejects MDMA for PTSD Treatment, Citing Data Concerns

Drug Approval Process

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