Medtech Insight 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


US FDA Might Face Funding Penalty For Missing User-Fee Goals

Executive Summary

Industry representatives support adding a provision to the user-fee agreements that would withdraw some taxpayer funding if the agency does not meet its deliverables.

You may also be interested in...

US FDA User-fee Bill Will Pressure Budget In 2023

A provision in the FDARA user-fee bill prevents FDA from spending user-fee revenue on building maintenance costs beginning in FY 2023, which could deter future recruitment and retention of the "world's best and brightest" scientists at FDA, House Energy and Commerce ranking member Frank Pallone says.

User Fees: Should US FDA Incur Penalties For Missed Deadlines?

Sen. Burr asks FDA whether fee revenue should be rebated for not meeting some PDUFA V goals.

Trump's Budget Outline Threatens User Fee Agreements

President wants substantially more user fee revenue than negotiated in user fee agreements, and some in industry already are warning that requiring increases now could endanger program reauthorizations.

Related Content


Latest Headlines
See All



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