CMC

• 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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• Optimizing Regulatory Frameworks for Gene Therapies in Rare Diseases: Challenges and solutions

  December 12, 2024 Position Paper Regulatory Policy , Clinical Development , CMC
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• RFI: Securing and Enhancing Biomedical Supply Chains

  October 04, 2024 Congress Regulatory Policy , CMC
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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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• 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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• Comments on Predecisional Draft NCATS Strategic Plan 2024- 2029 

  June 14, 2024 Miscellaneous Regulatory Policy , Clinical Development , CMC , Research Funding , New Technologies , NBS
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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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• 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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• ARM-FDA Roundtable on Potency Assays Summary

  April 01, 2023 Event Summary Regulatory Policy , Clinical Development , CMC
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• Addressing potency-assay related development delays for cell and gene therapies: Results of a scientific exchange between FDA and developers

  March 30, 2023 Position Paper Regulatory Policy , Clinical Development , CMC
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• Human Gene Therapy Products Incorporating Human Genome Editing Guidance

  June 14, 2022 FDA Regulatory Policy , Clinical Development , CMC , Bioethics , FDA Guidance
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• Considerations for the Development of CAR T Products Guidance

  June 10, 2022 FDA Regulatory Policy , Clinical Development , CMC , FDA Guidance
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• PDUFA VII Reauthorization

  February 11, 2022 Congress Regulatory Policy , Clinical Development , CMC , Congress
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• Prevent Pandemics Act Discussion Draft

  February 04, 2022 Congress Regulatory Policy , CMC , Congress , Research Funding
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• 21st Century Cures 2.0 [Introduced]

  December 30, 2021 Congress Regulatory Policy , Clinical Development , CMC , Bioethics , Congress , Research Funding , NBS
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