EPISODE · Oct 7, 2022 · 20 MIN
The Changing Environment Around Accelerated Approvals and Regulatory Pathways
from PharmaTalkRadio · host Conference Forum
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
What this episode covers
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
NOW PLAYING
The Changing Environment Around Accelerated Approvals and Regulatory Pathways
No transcript for this episode yet
Similar Episodes
No similar episodes found.
Similar Podcasts
No similar podcasts found.