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

NDA Review ‘Program’ On Track, But Is It Still Doomed?

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

PDUFA V granted FDA an additional two months to complete application reviews, but agency data indicates median review time, influenced by priority review speed, only increased by one month in FY 2013.

You may also be interested in...



PhRMA, BIO’s PDUFA V Application Tracker Could Inform “Course Corrections”

Members will enter data into secure database, allowing trade groups to gauge trends and problems with the PDUFA V application review program – and giving industry a stronger negotiating position for the next user fee round.

Buying Time: Industry Sacrifices Early To Gain Later With PDUFA V Review Model

NMEs and novel biologics will see reviews allotted two additional months under the revised model launching Oct. 1. Industry expects to gain more communication and first-cycle approvals, while FDA hopes it can receive more complete applications at submission and improve transparency.

US FDA Likely To Embrace In-Person, Remote Combo For Facility Inspections Going Forward

The system likely will evolve as the post-pandemic world unfolds, but adds to the list of agency programs expecting to continue using virtual platforms once in-person activities are no longer restricted by COVID-19.

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS005635

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