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22대 대한민국 국회 국회정보길라잡이 국회의원검색
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Title page 1

Contents 3

Highlights 2

Letter 5

Background 10

FDA Uses a Combination of Government-Wide Requirements and Internal Policies to Guide Its Conflict of Interest Review Process 11

Conflict of Interest Requirements and Review Process for FDA Advisory Committee Members 11

FDA Conflict of Interest Policies and Review Process for Advisory Committee Guest Speakers 17

FDA's Review Process for Opioid Committees Resulted in Recusals, a Waiver, and Public Disclosures 17

Advisory Committee Members 18

Guest Speakers and Open Public Hearing Speakers 22

FDA Makes Some of Its Advisory Committee Policies Public, But Has Not Shared How It Determines Certain Conflicts or Appearance Issues 25

FDA Publicly Shares Some of Its Advisory Committee Policies on Its Website 25

FDA Has Not Made Public How It Determines Conflicts of Interest or Appearance Issues for Advisory Committees 27

Conclusions 30

Recommendations for Executive Action 31

Agency Comments 31

Appendix I: Methodology for Stakeholder Selection 33

Appendix II: Results of Food and Drug Administration's Conflict of Interest Process 35

Appendix III: Comments from the Department of Health and Human Services 36

Appendix IV: GAO Contact and Staff Acknowledgments 38

Tables 3

Table 1. Select Waiver or Authorization Authorities for Advisory Committee Meetings 14

Table 2. Results of the Food and Drug Administration's (FDA) Conflict of Interest Review Process for Opioid-Related Advisory Committees... 19

Table 3. Total Counts of Non-Opioid Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Advisory... 35

Figures 4

Figure 1. Examples of Financial Interests the Food and Drug Administration (FDA) Reviews for Advisory Committee Meetings 13

Figure 2. Open Public Hearing Speaker Disclosures from the Food and Drug Administration's (FDA) 17 Most Recent Opioid-Related... 23

Figure 3. Food and Drug Administration (FDA) Advisory Committee Guidance Documents Website, as of March 2026 26

Figure 4. Food and Drug Administration (FDA) Advisory Committee Laws, Regulations, and Guidance Website, as of March 2026 27

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