U.S. Food and Drug Administration - Pre-ANDA Logistics and Best Practices (3of39) Complex Generics 2018 (YouTube)
Update: 2025-09-21
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Downloaded from U.S. Food and Drug Administration Youtube channel on 2025-02-08 09:29:01 https://youtube.com/watch?v=qnIWo_f4JSE -------- Kris Andre, Associate Director of Regulatory Affairs in CDER’s Office of Generic Drugs, covers submitting a meeting request through the portal, the pre-ANDA pro....
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