Policy Statements & Letters | Advocacy | ASGCT - American Society of Gene & Cell Therapy | ASGCT

Ensuring patient access to gene therapies for rare diseases: Navigating reimbursement and coverage challenges

January 29, 2025 Position Paper Clinical Development , Payment Policy

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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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SCD Comprehensive Care Act Sign On

November 14, 2024 Congress

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FDA AMT Strategic Plan

November 12, 2024 FDA

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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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Policy Statements

28th ASGCT Annual Meeting