Acceleration of new medicines–CMC lessons learned from emergency use authorizations
James Bernstein,
Kim Huynh-Ba,
Patrick Lynch,
Thomas Oliver,
Reza Oliyai,
Scott W. Roberts,
Andrea Schirmer,
David Schwinke,
Kin Tang,
Jessica Ursin
Affiliations
James Bernstein
Live Oak Pharmaceutical Consulting, Inc.
Kim Huynh-Ba
Pharmalytik Consulting, LLC
Patrick Lynch
Division of Biotechnology Review and Research II, Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Thomas Oliver
Division of New Drug Products I, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
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.
