New Technologies

• 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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• 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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• Written Testimony: Legislative Proposals to Support Patients with Rare Diseases

  March 19, 2024 Congress Clinical Development , Research Funding , New Technologies
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• Screening Framework for Providers of Synthetic Double-Stranded DNA

  June 29, 2022 HHS Bioethics , New Technologies
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• Nonclinical Biodistribtuion Considerations for Gene Therapy Products Guidance; International Council for Harmonisation

  November 05, 2021 FDA Regulatory Policy , CMC , FDA Guidance , New Technologies
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• Facilitating the Early Diagnosis and Equitable Delivery of Gene-Targeted Therapies

  June 22, 2021 Miscellaneous Regulatory Policy , Clinical Development , CMC , Bioethics , Payment Policy , Research Funding , New Technologies , NBS
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• Medicare Coverage of Innovative Technology

  November 02, 2020 CMS Regulatory Policy , Payment Policy , New Technologies
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• 21st Century Cures 2.0 Concept Paper

  October 21, 2020 Congress Regulatory Policy , Congress , Payment Policy , Research Funding , New Technologies
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• Standards for the Measurement of Pre-Existing Immunity to Adeno-Associated Virus Vector

  July 22, 2020 Position Paper Clinical Development , New Technologies
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• Draft Governance Framework

  February 07, 2020 Miscellaneous Regulatory Policy , Bioethics , New Technologies
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• Call for Evidence: Germline Gene Editing

  September 27, 2019 Miscellaneous Regulatory Policy , Bioethics , New Technologies
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• Clinical Application of Gene Editing

  August 16, 2019 Miscellaneous Regulatory Policy , Bioethics , New Technologies
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• Clinical Germline Gene Editing

  April 24, 2019 HHS Regulatory Policy , Bioethics , New Technologies
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• Pandemic and All-Hazards Preparedness and Advancing Innovation Act

  June 27, 2018 Congress Bioethics , Congress , New Technologies
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• ASGCT and JSGT Joint Position Statement on Human Genomic Editing

  August 03, 2015 Position Paper Regulatory Policy , Bioethics , New Technologies
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