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

UsernamePublicRestriction
UsernamePublicRestriction

US FDA Lays Out High And Low Options At MDUFA Talks

This article was originally published in Clinica

Executive Summary

Minutes from the most recent Medical Device User Fee Act negotiation meeting, posted by the US FDA, suggest regulators and industry are getting closer to agreeing on components of a MDUFA IV proposal. Returning to the negotiating table on May 16, the agency presented two proposals to industry that are approximately $30m apart.

Advertisement

Related Content

Generic User Fee Talks Reach 'Final Wording' But Still Not Done

Topics

Advertisement
UsernamePublicRestriction

Register

MT103539

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