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

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.
Patrizia Cavazzoni Peter Marks Gene Therapies Advisory Committee Pilot Program Trials Advancing Rare Biologics Evaluation
Source: ajmc.com

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