Outsourcing Facilities Annual Study
Compounding Outsourcing Facilities Annual Study
Gepotidacin – Oral Products
Gepotidacin – Oral Products
Americo F. Padilla, M.D. – 700447 – 03/25/2025
Clinical Investigator
Data Standards Catalog
Data Standards Catalog
BPI Labs, LLC – 699533 – 03/20/2025
Unapproved New Drugs/Misbranded
Aspen Biopharma Labs Private Limited – 698665 – 03/05/2025
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Hangzhou Glamcos Biotech Co., Ltd. – 692583 – 10/07/2024
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Yangzhou Sion Commodity Co., Ltd. – 699183 – 03/12/2025
CGMP/Finished Pharmaceutical/API/Adulterated
Food and Drug Omnibus Reform Act (FDORA) of 2022
The Food and Drug Omnibus Reform Act of 2022 (FDORA) requires FDA to develop several different kinds of informational documents,…
Prescription Drug Marketing Act of 1987
FDA’s implementation of the Prescription Drug Marketing Act of 1987