Medtech Insight 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

FDA Returns To MDUFA Table With High, Low Proposals

This article was originally published in The Gray Sheet

Executive Summary

The priorities-gap between FDA and industry in MDUFA IV negotiations is narrowing. In May, the agency returned with counter-proposals that reduce user-fee increases compared to its prior plans, though there is still at least a $160m difference from the most recent proposal that is public from industry.


Related Content

US FDA Plans New Office Of Patient Affairs
US Device User-Fee Rates Will Drop About 10.3% In Fiscal 2017





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

All set! This Question has been sent to 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

Add a personalized Question to your Analyst