What’s New in Clinical Trial Innovation (May 6, 2026 14:50)
The Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation...

Withdrawn | Cancer Accelerated Approvals (May 6, 2026 14:42)
This listing includes accelerated approvals (AAs) for malignant hematology and oncology...

Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present (May 6, 2026 14:39)
The following are the medical, statistical, and clinical pharmacology reviews of pediat...

Clinical Trials Day (May 6, 2026 13:47)
Clinical Trials Day is celebrated on May 20, in recognition of what is often considered...

BsUFA IV: Fiscal Years 2028-2032 (May 6, 2026 13:27)
On September 30, 2022, the President signed into law the FDA User Fee Reauthorization A...

Generic Drug User Fee Amendments (May 6, 2026 09:57)
This page features news and information for industry and stakeholders about GDUFA, its ...

Generic Drug Facilities, Sites and Organization Lists (May 6, 2026 09:53)
Generic Drug Facilities, Sites and Organization Lists