Covalent Medical – 695839 – 07/09/2025

Unapproved New Drugs/Misbranded

Scope Health Inc – 695085 – 07/09/2025

Unapproved New Drugs/Misbranded

Identification of Novel THC Analogs: Chloro Derivatives of Hexahydrocannabinol and Tetrahydrocannabibutol Butanoate in an Oil Product Obtained in Japan

Ten semi-synthetic THC analogs, including chlorinated cannabinoids, were identified in a vape oil product sold in Japan. ABSTRACT Since around…

PDUFA and BsUFA Quarterly Hiring Updates

PDUFA and BsUFA Quarterly Hiring Updates

Gastrointestinal Drugs Advisory Committee Roster

This page contains the Gastrointestinal roster, which lists the current members and the current number of vacancies for the committee.

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.…