Pink Sheet is part of the Business Intelligence Division 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


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.


Related Content

PDUFA VI: BIO Survey Finds FDA Communication Problems
PDUFA V Reviews Are ‘Best Ever’ For Some Sponsors, Maybe Not FDA
PDUFA V ‘Program’ Gets Positive Evaluation – Except For Inspections
NDA Review ‘Program’ On Track, But Is It Still Doomed?
Bayer/Algeta’s Xofigo Brings New Mechanism To Prostate Cancer Field
Buying Time: Industry Sacrifices Early To Gain Later With PDUFA V Review Model
GPhA’s Drug Shortage Initiative Clears FTC Hurdle; Still Working With FDA
FDASIA Is Signed, Not That White House Wanted Anyone To Notice
FDA Still Most Predictable Part of Drug Development, Despite Bumps, Woodcock Says
Want A Predicable Review For Your NDA? Use eCTD And Don't Amend It


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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