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Scientific Standards for Studies on Modified Risk Tobacco Products (2012)

Chapter: Appendix B: Chapters 1 and 2 from *Evaluation of Biomarkers andSurrogate Endpoints in Chronic Disease*

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Suggested Citation:"Appendix B: Chapters 1 and 2 from *Evaluation of Biomarkers andSurrogate Endpoints in Chronic Disease*." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
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Appendix B

Chapters 1 and 2 from
Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease1

_______________

1 Institute of Medicine. 2010. Evaluation of biomarkers and surrogate endpoints in chronic disease. Washington, DC: The National Academies Press

Page 258 Cite
Suggested Citation:"Appendix B: Chapters 1 and 2 from *Evaluation of Biomarkers andSurrogate Endpoints in Chronic Disease*." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
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Page 257 Cite
Suggested Citation:"Appendix B: Chapters 1 and 2 from *Evaluation of Biomarkers andSurrogate Endpoints in Chronic Disease*." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
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Page 257
Page 258 Cite
Suggested Citation:"Appendix B: Chapters 1 and 2 from *Evaluation of Biomarkers andSurrogate Endpoints in Chronic Disease*." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
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Page 258
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Smoking-related diseases kill more Americans than alcohol, illegal drugs, murder and suicide combined. The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority to regulate "modified risk tobacco products" (MRTPs), tobacco products that are either designed or advertised to reduce harm or the risk of tobacco-related disease. MRTPs must submit to the FDA scientific evidence to demonstrate the product has the potential to reduce tobacco related harms as compared to conventional tobacco products. The IOM identifies minimum standards for scientific studies that an applicant would need to complete to obtain an order to market the product from the FDA.

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