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CBER Reviewers Are Working with Sponsors in Exploring CMC Flexibility for Cell and Gene Therapies

Sep 28th, 2019

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Reviewers with FDA’s Center for Biologics Evaluation and Research (CBER) are working with sponsors to determine how and where flexibility can be applied in the type and extent of CMC information expected at the time of cell and gene therapy (CGT) product submissions.

Decisions will be made on a case-by-case basis and may apply to components such as process validation, manufacturing scale-up/scale-out strategies, and marketing commitments and requirements.

At a session on expedited development at the June 10-12 CASSS CGT Products Symposium held in Bethesda, Maryland, CBER Office of Tissues and Advanced Therapies (OTAT) Division of Cellular and Gene Therapies (DCGT) Branch Chief Steven Oh provided insight into how this flexibility is coming into play in addressing the CMC complexities that CGTs present in the context of foreshortened development and review timelines.

Oh offered examples of potential CMC flexibility in the biological license application (BLA) process that would not jeopardize the essential goal of ensuring that quality products are consistently produced and available at the time of approval.

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