For Industry
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FDA Rare Disease Patient Advocacy Day Presentations and Meeting Resources
All remaining slide sets will be posted within 2 weeks following the event date of March 1, 2012.
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Background Materials
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Plenary Session Presentations
Overview of the FDA and the Office of Orphan Products Development (OOPD) (PDF - 1023KB)
Gayatri R. Rao, M.D., J.D., Acting Director, FDA Office of Orphan Products DevelopmentRare Diseases Drug Development (PDF - 246KB)
Anne Pariser, M.D., Associate Director for Rare Diseases, FDA Office of New DrugsCenter for Bilogics Evaluation and Research: Products for Rare Diseases (PDF - 211KB)
Nisha Jain, M.D., Chief, Clinical Review Branch, FDA Office of Blood Research and ReviewRare Diseases from a Medical Device Perspective (PDF - 630KB)
Markham C. Luke, M.D., Ph.D., Deputy Director for Clinical Policy, FDA Office of Device EvaluationCDER Drug Shortage Program (PDF - 409KB)
CDR Emily Thakur, R.Ph., FDA Drug Shortage ProgramOffice of Special Health Issues (OSHI) (PDF - 1.1MB)
Richard Klein, FDA Office of Special Health IssuesNIH Rare Diseases Research (PDF - 265KB)
Stephen C. Groft, Pharm.D., Director, NIH Office of Rare Diseases Research- FDA Rare Disease Patient Advocacy Day (PDF - 126KB)
Frank J. Sasinowski, M.S., M.P.H., J.D., Chairman of the Board, National Organization for Rare Disorders
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Breakout Session Presentations
Grants for Rare Disease Research (PDF - 208KB)
Katherine Needleman, M.S., RAC, Director, FDA Orphan Products Grants ProgramRegulatory Science: Pathways to Innovation (PDF - 726KB)
Chris Leptak, M.D., Ph.D., FDA Office of New Drugs, Guidane and Policy TeamDevices for Rare Diseases (PDF - 85KB)
FDA Center for Devices and Radiological HealthDiagnostic Device Use Rare Diseases (PDF - 261KB)
FDA Center for Devices and Radiological HealthExpanded Access Programs (PDF - 129KB)
Richard Klein, FDA Office of Special Health Issues- FDA Rare Disease Patient Advocacy Day (PDF - 226KB)
Frank J. Sasinowski, M.S., M.P.H., J.D., Chairman of the Board, National Organization for Rare Disorders Orphan Drug Designation (PDF - 403KB)
FDA Office of Orphan Products DevelopmentCDER Drug Shortage Program (PDF - 409KB)
CDR Emily Thakur, R.Ph., FDA Drug Shortage ProgramRegulation of Medical Foods (PDF - 100KB)
Shawne Suggs-Anderson, MMSc, R.D., FDA Infant Formula and Medical Foods Staff
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