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National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union; Shore CK, Worku TL, Smith CW, et al., editors. Regulatory Processes for Rare Disease Drugs in the United States and European Union: Flexibilities and Collaborative Opportunities. Washington (DC): National Academies Press (US); 2024 Oct 30.
Regulatory Processes for Rare Disease Drugs in the United States and European Union: Flexibilities and Collaborative Opportunities.
Show details- JEFFREY P. KAHN (Chair), Andreas C. Dracopoulos Director and Levi Professor of Bioethics and Public Policy, Johns Hopkins Berman Institute of Bioethics
- RONALD J. BARTEK, President, Director, and Co-Founder, Friedreich’s Ataxia Research Alliance
- TERRY JO BICHELL, Founder and Director, COMBINEDBrain
- EDWARD A. BOTCHWEY, Professor, Georgia Tech and Emory University
- SHEIN-CHUNG CHOW, Professor of Biostatistics and Bioinformatics, Duke University School of Medicine
- HANS-GEORG EICHLER, Consulting Physician, Austrian Association of Social Insurance Bodies
- PAT FURLONG, Founding President and Chief Executive Officer, Parent Project Muscular Dystrophy
- STEVEN K. GALSON, Senior Advisor, Boston Consulting Group
- GAVIN HUNTLEY-FENNER, Principal Consultant, Huntley-Fenner Advisors
- ANAEZE C. OFFODILE II, Chief Strategy Officer, Memorial Sloan Kettering Cancer Center
- ANNE R. PARISER, Physician, Indian Health Service, Crow/Northern Cheyenne Hospital
- JONATHAN H. WATANABE, Professor of Clinical Pharmacy, Associate Dean of Assessment and Quality, University of California, Irvine, School of Pharmacy and Pharmaceutical Sciences
National Academies of Medicine Fellow
- SANKET DHRUVA, University of California, San Francisco
Study Staff
- CAROLYN K. SHORE, Study Co-Director and Senior Program Officer
- TEQUAM L. WORKU, Study Co-Director and Program Officer (as of March 2024)
- EESHAN KHANDEKAR, Study Co-Director and Program Officer (until March 2024)
- CARSON SMITH, Research Associate
- MELVIN JOPPY, Senior Program Assistant
- NOAH ONTJES, Associate Program Officer
- KYLE CAVAGNINI, Associate Program Officer (from April to June 2024)
- CLARE STROUD, Senior Board Director, Board on Health Sciences Policy
Consultants
- ERIN HAMMERS FORSTAG, Science Writer
- MAGDA BUJAR, Centre for Innovation in Regulatory Science
- ADEM KERMAD, Centre for Innovation in Regulatory Science
- JUAN LARA, Centre for Innovation in Regulatory Science
- NEIL McAUSLANE, Centre for Innovation in Regulatory Science
- ANNA SOMUYIWA, Centre for Innovation in Regulatory Science
Footnotes
- 1
See Appendix A: Disclosure of Unavoidable Conflicts of Interest
- COMMITTEE ON PROCESSES TO EVALUATE THE SAFETY AND EFFICACY OF DRUGS FOR RARE DIS...COMMITTEE ON PROCESSES TO EVALUATE THE SAFETY AND EFFICACY OF DRUGS FOR RARE DISEASES OR CONDITIONS IN THE UNITED STATES AND THE EUROPEAN UNION - Regulatory Processes for Rare Disease Drugs in the United States and European Union
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