New FDA Pilot Program Will Provide Hands-On Regulatory Guidance for Cell and Gene Therapy Trials in Rare Disease

AJMC October 7, 2023
Noah Stansfield

The program will initially allow 6 sponsors of clinical trials to participate and will provide sponsors with the opportunity for frequent advice and regular communication regarding clinical trial design and other development issues.

The Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program, an FDA initiative newly announced on September 29, 2023, includes provisions that may help smooth and speed up the path to approval for several clinical trials evaluating investigational cell therapies and/or gene therapies for rare disease indications.¹

The program, which will initially allow a total of 6 selected sponsors of clinical trials to participate, will provide sponsors with the opportunity for frequent advice and regular communication as needed with regard to clinical trial design and...

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