This session will provide insights into the How and the What of Agency pre-approval review of safety data in marketing applications via the 21st Century Review Process and JumpStart.

参加申し込み

Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Session 18: FDA Review of Clinical Trial Data in an NDA or BLA

Session Chair(s)

JP Clement, MD

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