Agenda Details

Learn more about sessions and presentations at the 25th Annual Meeting

Detailed Program

Effective Regulatory Interactions (Organized by the Regulatory Affairs Committee)

With the rapid expansion of gene and cell therapy clinical development, FDA CBER staff has been challenged to keep pace with the increased need for interactions to guide sponsors in development of these therapies. This symposium will address facilitation of more effective FDA/sponsor communication within this challenging environment. The session will begin with a 10-minute review of ASGCT's survey of members of clinically focused committees as was presented to OTAT during a listening session in June. FDA will provide an update on its efforts toward improving sponsor communications, both in response to listening sessions and based on anticipated outcomes of the Prescription Drug User Fee Act (PDUFA) reauthorization process. Industry speakers will address the PDUFA goals that may improve communications and provide recommendations on optimizing interactions with FDA at the IND and BLA stages of development. The symposium will end with a panel discussion moderated by the co-chairs.

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