Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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 Under Review By US FDA: Completing Confirmatory Trials A Focus

Executive Summary

Top officials want confirmatory trials to finish in a ‘reasonable amount of time’ and worry that ‘if 100% of them were able to confirm, then the bar’s too high.’

You may also be interested in...



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%.

Pazdurcanumab: US FDA’s Top Cancer Official Weighs In On That Big Neurology Approval

Richard Pazdur is eager for a conversation about how to improve the Accelerated Approval pathway. The OCE director welcomes aducanumab’s approval – both on its own terms but also as an opportunity to broaden the discussion.

Accelerated Approval: US FDA Review Of Expedited Program Could Bring More Withdrawals

Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals leads to removal of indications for two PD-1/L-1 inhibitors, AstraZeneca’s Imfinzi and Bristol-Myers Squibb’s Opdivo, both of which had failed confirmatory trials.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143236

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