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

Good Review Principles Implementation Could Threaten Six-Month Priority Review Timeframe

This article was originally published in The Pink Sheet Daily

Executive Summary

OND Director Jenkins tells FDC/Windhover conference that newly-defined best practices are difficult to accomplish within six months and "nearly impossible" if the priority application must face an advisory panel.

You may also be interested in...



First-Cycle Approval Rate Already High; Can PDUFA V Actually Boost It?

FDA official says the rate of approving applications in the first review cycle may not increase much more, even as the new review model, intended to promote more first-cycle approvals, has yet to finish with its inaugural applications.

PDUFA Talks: FDA Floats “Information Sharing” Pause In New Review Model

FDA’s new proposed review model would break the process into four distinct phases and eliminate some extensions of the review deadline, yet the actual review cycle still likely would be lengthened.

PDUFA Talks: FDA Floats “Information Sharing” Pause In New Review Model

FDA’s new proposed review model would break the process into four distinct phases and eliminate some extensions of the review deadline, yet the actual review cycle still likely would be lengthened.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS067188

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