Identification of Tetrahydrocannabidiol Metabolites in Human Urine
The detection of Phase I and II metabolites of tetrahydrocannabidiol (H4CBD) in urine after oral ingestion of 25-mg H4CBD by…
Drug Safety Oversight Board
The DSB is composed of representatives from two FDA Centers and eight other federal government agencies, the Agency for Healthcare…
FDA-TRACK: Prescription Drug User Fee Act Meeting Goals Summary
FDA-TRACK: Prescription Drug User Fee Act Meeting Goals Summary
FDA-TRACK: Prescription Drug User Fee Act Procedural Goals Summary
FDA-TRACK: Prescription Drug User Fee Act Procedural Goals Summary
FDA-TRACK: Prescription Drug User Fee Act Review Goals Summary
FDA-TRACK: Prescription Drug User Fee Act Review Goals Summary
Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee) Roster
This page contains the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee) Roster,…
Assessing Novel Efficacy Endpoints in Ophthalmologic Rare Disease Drug and Biologics Development – 09/17/2025
The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the U.S. Food and Drug Administration, is convening a…
FDA Approves Drug to Treat Adults with Persistent or Chronic Immune Thrombocytopenia
The U.S. Food and Drug Administration (FDA) approved Wayrilz (rilzabrutinib) tablets to treat adults with persistent or chronic immune thrombocytopenia…
Amneal Pharmaceuticals, LLC – 709894 – 08/27/2025
CGMP/Finished Pharmaceuticals/Adulterated
Chromatography Institute of America dba Compounder’s International Analytical Laboratory – 708944 – 08/20/2025
CGMP/Finished Pharmaceutical/API/Adulterated