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 ...
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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. Table of Contents Front Matter Summary 1 Introduction 2 Governance and Conduct of Studies 3 Evidence Base and Methods for Studying Health Effects 4 Methods for Investigating Addictive Potential 5 Methods for Studying Risk Perception and Risk Communication 6 Decision Making and Oversight of MRTP Studies: Findings and Recommendations Appendix A: Section 911 of the Family Smoking Prevention and Tobacco Control Act of 2009 Appendix B: Chapters 1 and 2 from *Evaluation of Biomarkers andSurrogate Endpoints in Chronic Disease* [Appendix B] 1 Introduction [Appendix B] 2 Review: Evaluating and Regulating Biomarker Use Appendix C: Committee Biographies Appendix D: Meeting Agendas
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Add this copy of Scientific Standards for Studies on Modified Risk to cart. $18.49, very good condition, Sold by Alien Bindings rated 5.0 out of 5 stars, ships from BALTIMORE, MD, UNITED STATES, published 2012 by National Academies Press.
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Very Good condition. The covers look great. The binding is tight. The interior pages are clean and unmarked. Former owner's name and stamp marked out on first page. USPS electronic tracking number issued free of charge. 370 pages.
Add this copy of Scientific Standards for Studies on Modified Risk to cart. $47.24, very good condition, Sold by The Maryland Book Bank rated 5.0 out of 5 stars, ships from baltimore, MD, UNITED STATES, published 2012 by National Academies Press.
Add this copy of Scientific Standards for Studies on Modified Risk to cart. $47.24, good condition, Sold by The Maryland Book Bank rated 5.0 out of 5 stars, ships from baltimore, MD, UNITED STATES, published 2012 by National Academies Press.
Add this copy of Scientific Standards for Studies on Modified Risk to cart. $73.32, new condition, Sold by Media Smart rated 4.0 out of 5 stars, ships from Hawthorne, CA, UNITED STATES, published 2012 by National Academy Press.
Add this copy of Scientific Standards for Studies on Modified Risk to cart. $78.38, good condition, Sold by Bonita rated 4.0 out of 5 stars, ships from Newport Coast, CA, UNITED STATES, published 2012 by National Academies Press.
