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FDA Rare Disease Town Hall
Session Chair(s)
James Valentine, JD, MHS
Director
Hyman, Phelps & McNamara, PC, United States
This annual town hall provides a forum for senior FDA officials to reflect on key trends and discuss opportunities in rare disease drug development and review. Officials answer moderated and audience burning questions facing the work that they do.
Learning Objective : Describe new FDA programs and initiatives intended to help facilitate development of drugs for rare diseases; Evaluate opportunities for sponsors and patient stakeholders to engage with regulators; Identify current trends in challenges and opportunities facing orphan drug development.
Speaker(s)
Perspectives on Rare Immunology & Inflammation Product Development
Nikolay Nikolov, MD
FDA, United States
Director, Office of Immunology and Inflammation, OND, CDER
Panelist
Amy Comstock Rick, JD
FDA, United States
Director of Strategic Coalitions, Rare Disease Innovation Hub
Perspectives on Rare Neuroscience Product Development
Teresa Buracchio, MD
FDA, United States
Director, Office of Neuroscience, OND, CDER
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