Improving the Sterility Assurance Application to the FDA – Generic Drugs Forum (GDF) 2024 [Video]

Dr. John Arigo, Director of the Division of Pharmaceutical Manufacturing Assessment II in the Office of Pharmaceutical Manufacturing Assessment within the Office of Pharmaceutical Quality at the FDA, discusses common deficiencies and concepts to improve the sterility assurance portion of an application.

Speakers | Panelists:
John Arigo, PhD
Division Director
Division of Pharmaceutical Manufacturing Assessment II (DPMA II) | Office of Pharmaceutical Manufacturing Assessment (OPMA) | Office of Pharmaceutical Quality (OPQ) | CDER

Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/generic-drugs-forum-gdf-2024-regulatory-considerations-enhance-generic-drug-access-04102024

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