FDA

• Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics

  March 06, 2025 FDA Regulatory Policy , Clinical Development , FDA Guidance
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• Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products

  February 17, 2025 FDA Regulatory Policy , Clinical Development , CMC , FDA Guidance
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• FDA AMT Strategic Plan

  November 12, 2024 FDA
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• Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies

  September 26, 2024 FDA Regulatory Policy , Clinical Development , Bioethics , FDA Guidance
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• Platform Technology Designation Program for Drug Development

  August 27, 2024 FDA Regulatory Policy , Clinical Development , CMC , FDA Guidance
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• Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products

  July 29, 2024 FDA Regulatory Policy , Clinical Development , FDA Guidance
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• Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products

  July 26, 2024 FDA Regulatory Policy , Clinical Development , CMC , FDA Guidance
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• Potency Assurance for Cellular and Gene Therapy Products

  March 26, 2024 FDA Regulatory Policy , Clinical Development , CMC , FDA Guidance
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• Advanced Manufacturing Technologies Designation Program

  March 05, 2024 FDA Regulatory Policy , Clinical Development , CMC , FDA Guidance
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• RFI: Scientific Challenges and Opportunities to Advance the Development of Individualized Cellular and Gene Therapies

  November 16, 2023 FDA Regulatory Policy , Clinical Development
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• Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products

  November 13, 2023 FDA Regulatory Policy , Clinical Development , CMC , FDA Guidance
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• Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches

  July 07, 2023 FDA Regulatory Policy , Clinical Development
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• Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on CGT Products Listening Session

  May 26, 2023 FDA Regulatory Policy , Clinical Development
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• Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Guidance

  May 02, 2023 FDA Regulatory Policy , Clinical Development , FDA Guidance
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• ARM-FDA Roundtable on Potency Assays White Paper

  April 14, 2023 FDA FDA Guidance
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• Ethical Considerations for Clinical Investigations of Medical Products Involving Children

  July 01, 2022 FDA Regulatory Policy , Clinical Development , Bioethics , FDA Guidance
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