Gene Editing

  1. Regulation and Governance
    1. National Regulatory Frameworks
      1. United States
        1. Food and Drug Administration
          1. Biologics Regulation
            1. Clinical Trial Oversight
              1. Approval Pathways
              2. National Institutes of Health
                1. Research Funding Guidelines
                  1. Recombinant DNA Advisory Committee
                  2. Centers for Disease Control
                    1. Public Health Oversight
                  3. European Union
                    1. European Medicines Agency
                      1. Centralized Approval Process
                        1. Scientific Advice
                        2. National Competent Authorities
                          1. GMO Regulations
                            1. Environmental Release
                              1. Food and Feed Safety
                            2. Other Major Jurisdictions
                              1. China
                                1. National Medical Products Administration
                                  1. Recent Policy Developments
                                  2. Japan
                                    1. Pharmaceuticals and Medical Devices Agency
                                    2. Canada
                                      1. Health Canada Oversight
                                      2. Australia
                                        1. Therapeutic Goods Administration
                                    3. International Coordination
                                      1. World Health Organization
                                        1. Global Standards Development
                                          1. Technical Guidance
                                            1. Capacity Building
                                            2. International Summits
                                              1. Human Genome Editing Summits
                                                1. Scientific Society Meetings
                                                  1. Policy Conferences
                                                  2. Professional Organizations
                                                    1. National Academies
                                                      1. Scientific Societies
                                                        1. Ethics Committees
                                                      2. Regulatory Challenges
                                                        1. Keeping Pace with Technology
                                                          1. International Harmonization
                                                            1. Risk-Benefit Assessment
                                                              1. Public Engagement
                                                                1. Adaptive Regulation

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                                                              12. Ethical, Legal, and Social Implications

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                                                              14. Future Directions and Emerging Technologies