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FDA Rare Disease Town Hall
Session Chair(s)
James Valentine, JD, MHS
Director, Hyman, Phelps & McNamara, PC, United States
This forum will address the unique regulatory complexities and challenges specific to orphan drug development. It will provide key information about programs available to expedite the development of orphan products and will include audience Q&A.
Learning Objective : Identify unique regulatory complexities and challenges specific to orphan drug development; Describe FDA programs available to expedite the development of orphan products.
Speaker(s)
Panelist
, Rocket Pharmaceuticals, Inc., United States
Panelist
Associate Director for Rare Diseases, Office of New Drugs, CDER, FDA, United States
Panelist
Senior Director, Global Regulatory Leader, Janssen Pharmaceutical Companies of Johnson and Johnson, United States
Panelist
Div of Translational and Precision Medicine, OCP, CDER, FDA, United States
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