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US FDA’s Woodcock Rejects Firewall Between Presubmission Advice And Application Review

 
• By Sue Sutter

Public Citizen proposal that FDA staff who provide presubmission advice on a development program not be involved in reviewing the subsequent product application would cause significant public health repercussions and delay drug development, acting commissioner says; Public Citizen had cited ‘close collaboration’ between the FDA and Biogen on aducanumab in calling for the separation.

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Public Citizen wanted a firewall separating CDER staff who provide presubmission advice from those who review drug applications. • Source: Shutterstock

The US Food and Drug Administration’s controversial review of Biogen, Inc.’s Alzheimer’s drug aducanumab will not result in a dramatic change in how agency review staff work with sponsors on drug development plans, at least not while Janet Woodcock is at the helm.

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