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Another Reorg For US FDA Drug Office: Dispute Resolution Program Moves Out

 
• By Derrick Gingery

In another sign of the increasing influence of generics within FDA, CDER Director Woodcock moves the formal dispute resolution program out of the Office of New Drugs.

FDA entrance sign 2016

In another sign of the the growing prominence of generics at the US FDA, the Center for Drug Evaluation and Research's formal dispute resolution program is moving out of the Office of New Drugs.

Most of the appeals now reviewed involve generics, Center for Drug Evaluation and Research Director Janet Woodcock said in the announcement of the organizational change June 7. The Formal Dispute...

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