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2022 ISPE Annual Meeting & Expo

SES108d - Regulatory Update on Cell and Gene Therapy: Perspectives from an Ex-OTAT/CBER/FDA Medical Officer


Oct 31, 2022 1:45pm ‐ Oct 31, 2022 3:15pm


Description

Steve will discuss developments that are relevant for cell and gene therapy sponsors, with a focus on recent publicly available information and comments from FDA and their implication on the Agency’s Benefit-Risk assessment and Expedited Development Pathways for CGT products. Additionally, the presentation will cover important aspects of The Prescription Drug User Fee Act (PDUFA VII) for CGT development programs.

Speaker(s):

  • Steve Winitsky, MD, Vice President, Technical Regulatory & Access, KMI/PAREXEL Inc

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