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US FDA's Rare Diseases Program Not Expected To Change With Drug Office Reorg

 
• By Derrick Gingery

Reviewer expertise may be better leveraged in more focused roles, but basic tenets of rare disease program should not fundamentally change as part of proposed Office of New Drugs reorganization.

FDA entrance sign 2016

BOSTON – The reorganization of the US FDA's Office of New Drugs is not expected to significantly affect its rare disease program, even though it is proposed to move to a new review division.

Lucas Kempf, acting associate director of the OND rare diseases program, said June 27 that he was assured by Center for Drug Evaluation and Research Director Janet Woodcock, who also...

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