基本説明
According to the book, the FDA should apply the same rigor to evaluating the science behind claims of helath benefits in food and nutritional supplement labeling as it devotes to assessing medication and medical technology approvals when biomarkers are involved.
Full Description
Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.
Contents
1 Front Matter; 2 Summary; 3 1 Introduction; 4 2 Review: Evaluating and Regulating Biomarker Use; 5 3 The Biomarker Evaluation Process; 6 4 Case Studies; 7 5 Strengthening Evidence-Based Regulation; 8 Acronyms; 9 Glossary; 10 Appendix A: Table of Papers About Biomarker Qualification; 11 Appendix B: Recommendations from Related IOM Reports; 12 Appendix C: Committee Member and Consultant Biographies; 13 Appendix D: Staff Biographies; 14 Appendix E: Workshop Agenda; 15 Appendix F: Speaker Biographies
