Medtech Insight 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

Industry Challenges FDA's User Fee Markup

This article was originally published in The Gray Sheet

Executive Summary

During the first round of user fee negotiations, industry questioned FDA's estimated cost of $750 million needed to continue the device user fee program between 2018 and 2022. Lobby groups for the device industry continue to emphasize user fees should supplement congressional appropriations to pay for FDA's review of devices.

You may also be interested in...



Virtual FDA-Industry MDUFA Negotiations To Kick Off After Months Of Delay

The US FDA and industry stakeholders are set to finally start monthly user fee negotiations online by February. The process has already been significantly delayed due to the pandemic and recent holidays.

FDA, Industry Agree On Working Groups To Support User-Fee Negotiations

The agency and industry agreed to create working groups allowing subject-matter experts to delve deeper into technical details on some of the key proposals raised thus far in user-fee reauthorization talks. Areas of focus include de novo reviews, pre-submissions and personnel recruitment challenges.

New Fundings And Goals To Match Raised In Latest MDUFA IV Session

As the number of de novo applications and pre-submission consultations keep growing, FDA is proposing to institute provide new funding for these programs, among a range of additional proposals laid out in a recent closed-door negotiation. The agency's plan aligns somewhat with an industry proposal, according to meeting minutes, but there is also a lot to negotiate.

Related Content

Topics

UsernamePublicRestriction

Register

OM008605

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

Cancel