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Last Updated: October 3, 2026
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Sally Choe, PhD, Director of the This presentation provided an overview of the pre-ANDA scientific meeting process related to topics that provide prospective ... This session provided an overview of ANDA labeling-related topics to help applicants provide high quality labeling submissions ... This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment ... Michael Kopcha, PhD, RPh, Director, This session covered in detail the nuances considered for inactive ingredient (IIG) Controlled Correspondence reviews.
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