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

• Main Authors: Marquerita Algorri (Author), Ajay Acharya (Author), James Bernstein (Author), Nina S. Cauchon (Author), Xiao Hong Chen (Author), Kim Huynh-Ba (Author), Carol Krantz (Author), Tao Li (Author), Yiwei Li (Author), Sherita McLamore (Author), Scott W. Roberts (Author), David Schwinke (Author), Rakhi Shah (Author), Andrea Schirmer (Author), Helen Strickland (Author), Kin Tang (Author), Timothy Watson (Author)
• Format: Book
• Published: SpringerOpen, 2022-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...