Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid

Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid

Abstract The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Controls (CMC) Community hosted two virtual panel discussions focusing on several novel regulatory review pathways for innovative oncology products: Real-Time Oncology Review (RTOR), Project Orbis, an...

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Bibliographic Details
Main Authors: Marquerita Algorri, Ajay Acharya, James Bernstein, Nina S. Cauchon, Xiao Hong Chen, Kim Huynh-Ba, Carol Krantz, Tao Li, Yiwei Li, Sherita McLamore, Scott W. Roberts, David Schwinke, Rakhi Shah, Andrea Schirmer, Helen Strickland, Kin Tang, Timothy Watson
Format: Article
Language:English
Published: SpringerOpen 2022-12-01
Series:AAPS Open
Subjects:
Regulatory
FDA
Regulatory efficiency
Accelerated review
Chemistry, Manufacturing, and Controls
Project Orbis
Online Access:https://doi.org/10.1186/s41120-022-00066-1

Internet

https://doi.org/10.1186/s41120-022-00066-1

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