Psychopharmacologic Drugs Advisory Committee Roster
Psychopharmacologic Drugs Advisory Committee Roster
Completed PDUFA VII Deliverables
Since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, user fees have played an important role…
Peripheral and Central Nervous System Drugs Advisory Committee Roster
This page contains the Peripheral and Central Nervous System Drugs Advisory Committee Roster, which lists the current members and the…
FDA Public Workshop: Future Needs for the Development of Interchangeable Products – 09/19/2025
The public meeting will be held on September 19, 2025, from 9 a.m. to 1 p.m. The meeting agenda, federal…
Post‐Mortem Identification and Toxicological Findings of Fluetonitazepyne and Isotonitazepyne
In early 2025, five death cases in Finland tested positive for fluetonitazepyne and one for isotonitazepyne in urine drug screening.…
Avoid Falsely Accusing Female Athletes Who Use Levonorgestrel of Doping
Levonorgestrel, a hormonal contraceptive, metabolises to 18-methyl-19-noretiocholanolone which is also the main metabolite of the prohibited substance 18-methyl-19-nortestosterone. Analysing for…
Avoid Falsely Accusing Female Athletes Who Use Levonorgestrel of Doping
Levonorgestrel, a hormonal contraceptive, metabolises to 18-methyl-19-noretiocholanolone which is also the main metabolite of the prohibited substance 18-methyl-19-nortestosterone. Analysing for…
Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals
This dataset provides a listing of all New Molecular Entities (NMEs) approved from 1985 – 2019 and regulated by the…
FDA Embraces Radical Transparency by Publishing Complete Response Letters
The FDA today published more than 200 decision letters, known as complete response letters (CRLs).
Post‐Mortem Identification and Toxicological Findings of Fluetonitazepyne and Isotonitazepyne
In early 2025, five death cases in Finland tested positive for fluetonitazepyne and one for isotonitazepyne in urine drug screening.…