FDA Issues Six Draft Guidances for Specific Disease Trials

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FDA Issues Six Draft Guidances for Specific Disease Trials

Agency Also Posts ICH Draft Guidance on Trial Adaptive Designs, Draft Guidance on Innovative Designs for CGT Trials

J.W. Schomisch

October 3, 2025 at 02:11 PM EST

The FDA released six draft guidances recently dealing with issues in conducting clinical trials for the development of drugs for specific diseases and conditions. They are: Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations; Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Development of Non-Op... Read More

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FDA Issues Six Draft Guidances for Specific Disease Trials

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