UPDATED MEETING DATE AND PUBLIC PARTICIPATION INFORMATION: May 5, 2025 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement – 05/05/2025

Sato Pharmaceutical Co., Ltd. – 11/21/2025. Country: Japan. Record Type: 483

CGMP/Finished Pharmaceuticals/Adulterated

Post-Warning Letter Meetings Under GDUFA

DPMH oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population and to improve pregnancy and lactation-related information in product labeling.

As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program