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

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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Bibliographische Detailangaben
Veröffentlicht in:	AAPS Open 2024-12, Vol.10 (1), p.2-7, Article 2
Hauptverfasser:	Bernstein, James, Huynh-Ba, Kim, Lynch, Patrick, Oliver, Thomas, Oliyai, Reza, Roberts, Scott W., Schirmer, Andrea, Schwinke, David, Tang, Kin, Ursin, Jessica
Format:	Artikel
Sprache:	eng
Schlagworte:	Accelerated regulatory pathways Biological products Biological products industry Biomedical and Life Sciences Biomedicine Case studies Chemistry Chemistry, Manufacturing, and Controls COVID-19 Drug Development Initiatives for Global Health Emergency preparedness Emergency use authorization FDA approval Infectious diseases International economic relations Manufacturing Meeting Report Pandemics Pharmaceutical Sciences/Technology Pharmaceuticals Pharmacology/Toxicology
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Beschreibung
Zusammenfassung:	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.
ISSN:	2364-9534 2364-9534
DOI:	10.1186/s41120-023-00089-2