Bioethics

• 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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• 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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• Diversity Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Trials Guidance

  June 13, 2022 Congress Regulatory Policy , Clinical Development , Bioethics , FDA Guidance
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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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• 21st Century Cures 2.0

  July 16, 2021 Congress Regulatory Policy , Clinical Development , CMC , Bioethics , Congress , Payment Policy , Research Funding , NBS
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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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• Gene Therapy for Neurodegenerative Disease Guidance

  April 06, 2021 FDA Regulatory Policy , Clinical Development , CMC , Bioethics , FDA Guidance
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• Multiple Myeloma Draft Evidence Report

  March 11, 2021 Miscellaneous Clinical Development , Bioethics , Payment Policy
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• Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biologic Products Guidance

  March 19, 2020 FDA Regulatory Policy , Clinical Development , Bioethics , FDA Guidance
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• Draft Governance Framework

  February 07, 2020 Miscellaneous Regulatory Policy , Bioethics , New Technologies
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• Use of Unproven Stem Cell Products

  January 29, 2020 State Legislators Regulatory Policy , Bioethics
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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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• Value of Gene Therapy and Patient Access White Paper

  December 01, 2018 Miscellaneous Regulatory Policy , Clinical Development , Bioethics , Payment Policy
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