Regulatory Policy

• 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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• 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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• 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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• Hospital Outpatient Prospective Payment System Proposed Rule - Sign On

  September 09, 2024 CMS Regulatory Policy , Payment Policy
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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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• Hospital Outpatient Prospective Payment System Proposed Rule

  August 09, 2024 CMS Regulatory Policy , Payment Policy
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• Medicare Physician Fee Schedule Proposed Rule

  August 09, 2024 CMS Regulatory Policy , Payment Policy
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• Request for Information from Stakeholders on the Enacted Cures 2.0 Act

  August 02, 2024 Congress Regulatory Policy , Clinical Development , Research Funding , New Technologies
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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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• 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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• Inpatient Prospective Payment System Proposed Rule - Sign on

  June 10, 2024 CMS Regulatory Policy , Payment Policy
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• Inpatient Prospective Payment System Proposed Rule

  June 10, 2024 CMS Regulatory Policy , Payment Policy
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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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