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FDA Rare Disease Town Hall
Session Chair(s)
James Valentine, JD, MHS
Director
Hyman, Phelps & McNamara, PC, United States
Hear from senior FDA leadership about challenges and opportunities in reviewing drugs for rare diseases. Representatives from key Agency Offices/Centers will provide updates on key trends and initiatives, then will discuss hot topic questions.
Learning Objective : Discuss recent trends in the development and FDA review of orphan drugs; Explain new and ongoing FDA policies and initiatives to facilitate the development of drugs for rare diseases; Identify opportunities to further address the challenges associated with rare disease medical product development.
Speaker(s)
Panelist
Kerry Jo Lee, MD
FDA, United States
Assoc. Dir. for Rare Diseases; Program Manager, Advancing Rare Disease Cures Pro
Panelist
Peter W. Marks, MD, PhD
FDA, United States
Director, Center for Biologics Evaluation and Research
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