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

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

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

You may also be interested in...



PDUFA VI: BIO Survey Finds FDA Communication Problems

Data may help industry stake out its negotiating position as formal talks near for user fee reauthorization.

PDUFA V Reviews Are ‘Best Ever’ For Some Sponsors, Maybe Not FDA

FDA officials suggest allowing late-cycle meeting opt-out and question the impact of the new lengthened review system in interim assessment of the ‘Program.’

PDUFA V ‘Program’ Gets Positive Evaluation – Except For Inspections

Longer application review time has been producing the improved communication sponsors expected, but modifications to the user fee program have yet to make inspections go smoother.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS075881

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