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

Accelerated Approval: How The Aduhelm Probes Will, And Won’t, Impact The Debate

Executive Summary

Even as the US FDA can expect to be put through the ringer with the congressional and HHS Inspector General probes, the process could have some upsides for the agency, according to former officials who have been through such scrutiny.

You may also be interested in...



US FDA Neuroscience Office Director Billy Dunn Departs As Agency Faces New Review Challenges

Dunn is retiring after an 18-year career that included involvement in some high-profile and controversial drug approval decisions, not the least of which is Biogen’s Alzheimer’s treatment Aduhelm; deputy director Teresa Buracchio takes over the neurology office on an acting basis.

US FDA’s Post-Aduhelm Reforms Include Updated Alzheimer’s Development Guidance, Record-Keeping On Sponsor Meetings

Agency already had an action plan in hand to address concerns with the aducanumab review even before the controversial approval, but it has not been fully implemented yet. A House committee report is another nudge.

Lessons From Aduhelm: Don’t Go Over Your FDA Review Team’s Head, Pazdur Says

US FDA’s oncology chief says he won’t talk to sponsors unilaterally when a company takes issue with their review division. Pazdur also weighed in on his long-term career plans and his views on the FDA-industry revolving door at two ASCO interviews. 

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS145810

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