Advocacy | ASGCT - American Society of Gene & Cell Therapy | ASGCT

Proposed Regulatory Updates to the Medicaid Drug Rebate Program

July 25, 2023 CMS Regulatory Policy , Payment Policy

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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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Inpatient Prospective Payment System Proposed Rule

June 07, 2023 CMS Regulatory Policy , Payment Policy

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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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Medicaid coverage practices for approved gene and cell therapies: Existing barriers and proposed policy solutions

May 16, 2023 Position Paper Regulatory Policy , Payment Policy

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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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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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ASAE Power of Associations Sign On

March 27, 2023 Congress Congress

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Request for Information: National Biotechnology and Biomanufacturing Initiative

January 20, 2023 OSTP

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FY23 Appropriations Omnibus

December 06, 2022 Congress Congress , Research Funding

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Sickle Cell Disease Comprehensive Care Act

November 17, 2022 Congress Congress

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Medicare Physician Fee Schedule 2023

September 06, 2022 CMS Regulatory Policy , Payment Policy

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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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Screening Framework for Providers of Synthetic Double-Stranded DNA

June 29, 2022 HHS Bioethics , New Technologies

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Inpatient Prospective Payment System and Long-Term Care Hospital Proposed Rule

June 17, 2022 CMS Regulatory Policy , Payment Policy

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Policy Statements

Proposed Regulatory Updates to the Medicaid Drug Rebate Program

Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches

Inpatient Prospective Payment System Proposed Rule

Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on CGT Products Listening Session

Medicaid coverage practices for approved gene and cell therapies: Existing barriers and proposed policy solutions

Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Guidance

ARM-FDA Roundtable on Potency Assays White Paper

Addressing potency-assay related development delays for cell and gene therapies: Results of a scientific exchange between FDA and developers

ASAE Power of Associations Sign On

Request for Information: National Biotechnology and Biomanufacturing Initiative

FY23 Appropriations Omnibus

Sickle Cell Disease Comprehensive Care Act

Medicare Physician Fee Schedule 2023

Ethical Considerations for Clinical Investigations of Medical Products Involving Children

Screening Framework for Providers of Synthetic Double-Stranded DNA

Inpatient Prospective Payment System and Long-Term Care Hospital Proposed Rule

ASGCT Policy Summit