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.

Have an account?

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

Be informed and stay engaged.