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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.

Wall
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.

In her role as acting commissioner, Woodcock has rejected Public Citizen Health Research Group’s request that FDA staff who provide presubmission advice on a drug development program not be

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