Rare Diseases and Orphan Products:

Accelerating Research and Development

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Size: 442 pages, 6 x 9

Publication Year:2011

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PAPERBACK ISBN-10: 0-309-15806-0 ISBN-13: 978-0-309-15806-0	$44.00	Add to Cart

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Authors:
Marilyn J. Field and Thomas F. Boat, Editors; Committee on Accelerating Rare Diseases Research and Orphan Product Development; Institute of Medicine
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Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases ...
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Table of Contents
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Front Matter	i-xxii
Summary	1-14	(skim)
1 Introduction	15-40	(skim)
2 Profile of Rare Diseases	41-72	(skim)
3 Regulatory Framework for Drugs for Rare Diseases	73-110	(skim)
4 Discovery Research for Rare Diseases and Orphan Product Development	111-146	(skim)
5 Development of New Therapeutic Drugs and Biologics for Rare Diseases	147-178	(skim)
6 Coverage and Reimbursement: Incentives and Disincentives for Product Development	179-204	(skim)
7 Medical Devices: Research and Development for Rare Diseases	205-240	(skim)
8 Toward an Integrated Approach to Accelerating Research and Product Development for Rare Diseases	241-248	(skim)
References	249-282	(skim)
Appendix A: Study Activities	283-290	(skim)
Appendix B: Innovation and the Orphan Drug Act, 1983-2009: Regulatory and Clinical Characteristics of Approved Orphan Drugs	291-308	(skim)
Appendix C: Medicare Part D Coverage and Reimbursement of Orphan Drugs	309-344	(skim)
Appendix D: Glossary, Abbreviations, and Public Laws	345-364	(skim)
Appendix E: Rare Diseases Clinical Research Network	365-370	(skim)
Appendix F: Advocacy Group Approaches to Accelerating Research and Product Development: Illustrative Examples	371-386	(skim)
Appendix G: Committee and Staff Biographies	387-394	(skim)
Index	395-420	(skim)

Rare Diseases and Orphan Products:

Accelerating Research and Development

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