Pink Sheet is part 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

UsernamePublicRestriction
UsernamePublicRestriction

Surge In Applications Triggers User Fee Inflation

Executive Summary

With full NDA and BLA submissions to FDA now growing faster than INDs and supplements, user fees are increasing more rapidly as well.

You may also be interested in...



What Goes Up … US FDA Expects 2016 NME Approval Total To Come Down

After a record-setting 2015 for new drug approvals, there were not enough applications with user fee goals in 2016 to reach that level again.

PDUFA Fees Forced Down For FY 2017 Due To Refund Provision

Final year of this user fee cycle will include 14% discount, but agency says it is ready for revenue reduction.

PDUFA Fees Forced Down For FY 2017 Due To Refund Provision

Final year of this user fee cycle will include 14% discount, but agency says it is ready for revenue reduction.

Related Content

Topics

UsernamePublicRestriction

Register

PS057063

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

Cancel