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US FDA 'Uni-Review' Rolls Out: Psychiatric Division Is Among Early Adopters

 
• By Kate Rawson

Shared review memorandum under Office of New Drugs reorg will help eliminate last-minute surprises between disciplines and provide greater consistency between divisions.

FDA entrance sign 2016

The US Food and Drug Administration’s Division of Psychiatry Products has one of the first review teams currently testing out the agency’s proposed new integrated review document as part of the “modernization” of the Office of New Drugs.

“We are early adopters, so we’re going to be piloting this new integrated review process with an application” that is...

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