Pharmatalkradio
The Changing Environment Around Accelerated Approvals and Regulatory Pathways
- Autor: Vários
- Narrador: Vários
- Editor: Podcast
- Duración: 0:21:00
- Mas informaciones
Informações:
Sinopsis
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
