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Center Of Excellence Not Best Model For US FDA Rare Disease Program, Woodcock Says

 
• By Derrick Gingery

Center for Drug Evaluation and Research Director says rare disease reviews need multiple specialists, which likely would not fit into a centralized rare disease review group.

FDA entrance sign 2016

A "very rigid" structure for a rare disease center of excellence would not necessarily improve application reviews or the program's' visibility within the US FDA, Janet Woodcock, director of the Center for Drug Evaluation and Research, told advocates.

The future of application review across CDER is a more flexible review team structure, where expertise from many different specialties can be accessed as needed

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