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The Changing Environment Around Accelerated Approvals and Regulatory Pathways
- Author: Vários
- Narrator: Vários
- Publisher: Podcast
- Duration: 0:21:00
- More information
Informações:
Synopsis
In this session recorded at CMO Summit 2022, panelists share strategy trends and opportunities around accelerated approvals and regulatory designations. Additionally, they discuss: How to approach the FDA based on the different types of meetingsHow these trends and pathways affect trial designImplications after approval based on the pathway Speakers: Edith Perez, MD, CMO, Bolt BiotherapeuticsJeffrey Bornstein, MD, CMO, Eledon PharmaceuticalsAmy Blawas, PhD, Principal Consultant, NDA Group
