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

Oncology Accelerated Approval Re-Reviews: US FDA’s Pazdur Is Not Backing Down

Executive Summary

How has FDA suddenly been able to enforce accelerated approval commitments in oncology? The agency’s Richard Pazdur reflects on lessons from 2021 – and promises more re-reviews to come.

You may also be interested in...



US FDA Tries To Shape The Accelerated Approval Reform Narrative

Indicating that failure should be expected may be a subtle reminder of the potential consequences of placing more guardrails on the expedited approval pathway.

Unger Unplugged: FDA Needs Accelerated Approval To ‘Take More Chances’ – But Also A Clear Path To Withdrawal

Former cardiology review office director Ellis Unger suggests 70% chance for AA drugs to confirm benefit is an appropriate benchmark, but agency comes nowhere close to withdrawing the remaining 30%.

Yo-Yo Approvals? Maybe Accelerated Approval Isn’t Fixed After All

Oncopeptides’ reversal on Pepaxto may or may not prove to be the right decision – but it underscores the inherent limits to US FDA’s efforts to police ‘dangling’ accelerated approvals.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS145424

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