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1. Acceleration of new medicines–CMC lessons learned from emergency use authorizations

Author

James Bernstein, Kim Huynh-Ba, Patrick Lynch, Thomas Oliver, Reza Oliyai, Scott W. Roberts, Andrea Schirmer, David Schwinke, Kin Tang, and Jessica Ursin

Subjects
Emergency use authorization, Accelerated regulatory pathways, Chemistry, Manufacturing, and Controls, COVID-19, Therapeutics. Pharmacology, RM1-950, Pharmacy and materia medica, RS1-441
Abstract

Abstract The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Control (CMC) Community hosted a virtual panel discussion on July 15, 2022, to provide a forum to discuss industry and regulator CMC challenges associated with emergency use authorizations.

Published
2024
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