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21:33
YouTube
U.S. Food and Drug Administration
GDF 2024 | D1S07 - Overview of the FDA Product-Specific Guidance (PSG) Program
This presentation provided an overview of the FDA Product-Specific Guidance (PSG) Program and explained its background and relationship to the Abbreviated New Drug Application (ANDA) program. The session covered the PSG program structure, GDUFA III commitments, and public comments and requests processes. GDUFA III PSG teleconferences (T-Cons ...
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