Feedback on the FDA draft guidance for industry studying multiple versions of a cellular or gene therapy product in an early phase clinical trial

A cross collaboration of members participated in a series of meetings to review FDA Feedback on the FDA draft guidance for industry studying multiple versions of a cellular or gene therapy product in an early phase clinical trial which was published for public consultation September 2021.

A summary document detailing consolidated feedback and suggested recommendations that represented the views of member companies was submitted to the FDA in December 2021 for consideration.

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