Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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

Executive Summary

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.

You may also be interested in...



She Didn’t Need To Be Commissioner: Janet Woodcock’s Transformative Legacy

She is as polarizing as she is powerful, but whether you think Janet Woodcock is drug development’s hero or public health’s enemy, there’s no denying she dramatically transformed the US FDA over her 35-year career.

FDA Neuroscience Director Dunn's Appearance At Tanezumab AdComm Confirms Neurology Office Is Intact

Dunn’s participation at the panel meeting ended speculation that he left the US FDA.

Woodcock Has Big, Quiet Supporter In Her Bid For US FDA Commissioner

Industry groups, along with many rare disease and patient advocacy groups, appear behind the acting commissioner getting the permanent position.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS143812

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel