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 Argues Very Few Accelerated Approvals Remain On Market Without Confirmation

Executive Summary

Of products that have had accelerated approval for at least a decade, just 6% are still marketed without the promised confirmatory evidence. And those include cases like ‘antibiotics approved for inhalational anthrax, where the lack of confirmatory clinical trial is a good thing.’ FDA’s Corrigan-Curay says.

You may also be interested in...



Excuses, Excuses: How ‘Delayed’ Confirmatory Trials Are Explained By FDA

US FDA currently reports about two dozen Accelerated Approval having ‘delays’ in the confirmatory trials. COVID is one factor in some – and the agency also appears to be clearing out some of the others.

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.

The Real ‘Pill Penalty’: US Biosimilar Law, Not The IRA

Biopharma industry is making some modest headway in quest to change the new US Medicare drug price process to treat drugs and biologics on equal footing. But eliminating the so-called ‘pill penalty’ would not on its own equalize the incentives for small molecule and large molecule R&D.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS145907

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