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.
Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. https://doi.org/10.17226/12869.
|2 Review: Evaluating and Regulating Biomarker Use||33-96|
|3 The Biomarker Evaluation Process||97-130|
|4 Case Studies||131-196|
|5 Strengthening Evidence-Based Regulation||197-234|
|Appendix A: Table of Papers About Biomarker Qualification||253-278|
|Appendix B: Recommendations from Related IOM Reports||279-286|
|Appendix C: Committee Member and Consultant Biographies||287-298|
|Appendix D: Staff Biographies||299-304|
|Appendix E: Workshop Agenda||305-306|
|Appendix F: Speaker Biographies||307-314|
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