AAPS Open (Mar 2024)

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

DOI
https://doi.org/10.1186/s41120-023-00089-2
Journal volume & issue
Vol. 10, no. 1
pp. 1 – 7

Abstract

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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.

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