Rare Diseases and Orphan Products: Accelerating Research and Development

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Rare Diseases and Orphan Products: Accelerating Research and Development (2011)
Board on Health Sciences Policy (HSP)

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. "Front Matter." Rare Diseases and Orphan Products: Accelerating Research and Development. Washington, DC: The National Academies Press, 2011.

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Rare Diseases and Orphan Products: Accelerating Research and Development

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Front Matter (R1-R22)

Summary (1-14)

1 Introduction (15-40)

2 Profile of Rare Diseases (41-72)

3 Regulatory Framework for Drugs for Rare Diseases (73-110)

4 Discovery Research for Rare Diseases and Orphan Product Development (111-146)

5 Development of New Therapeutic Drugs and Biologics for Rare Diseases (147-178)

6 Coverage and Reimbursement: Incentives and Disincentives for Product Development (179-204)

7 Medical Devices: Research and Development for Rare Diseases (205-240)

8 Toward an Integrated Approach to Accelerating Research and Product Development for Rare Diseases (241-248)

References (249-282)

Appendix A: Study Activities (283-290)

Appendix B: Innovation and the Orphan Drug Act, 1983-2009: Regulatory and Clinical Characteristics of Approved Orphan Drugs (291-308)

Appendix C: Medicare Part D Coverage and Reimbursement of Orphan Drugs (309-344)

Appendix D: Glossary, Abbreviations, and Public Laws (345-364)

Appendix E: Rare Diseases Clinical Research Network (365-370)

Appendix F: Advocacy Group Approaches to Accelerating Research and Product Development: Illustrative Examples (371-386)

Appendix G: Committee and Staff Biographies (387-394)

Index (395-420)

Free PDF Access

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Related Titles

Rare Diseases and Orphan Products: Accelerating Research and Development (2011) Board on Health Sciences Policy (HSP)

Citation Manager

Rare Diseases and Orphan Products: Accelerating Research and Development (2011)
Board on Health Sciences Policy (HSP)