FDA has identified significant data integrity and study conduct concerns with bioequivalence and bioavailability studies conducted by Raptim Research Pvt.…

This technical specifications document represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.

May 5, 2025: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug…

Meetings, conferences, and workshops sponsored or co-sponsored by Center for Drug Evaluation and Research.

The workshop will clarify the intent of FDA recommendations for IVPT studies, with step-by-step demonstrations illustrating how IVPT study procedures…

CDER Data Standards Program

The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program…

Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis. Monitor liver…

Science-based health and safety information you can trust.