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Your search keyword '"Accelerated regulatory pathways"' showing total 2 results
Start Over Descriptor "Accelerated regulatory pathways" Publication Year Range Last 3 years
2 results on '"Accelerated regulatory pathways"'

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

Author

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

Subjects
FORUMS
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. [ABSTRACT FROM AUTHOR]

Published
2024
Full Text
View/download PDF

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