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

PDUFA First: Fees To Support US FDA Device Center Staff

Executive Summary

To enhance combination product reviews, drug-fee revenue will pay for related positions in the agency's Center for Devices and Radiological Health.

You may also be interested in...



User-Fee Facts: 10 Key Medtech Details From US FDA Agreements

While Congress makes its push to reauthorize US FDA user fees by mid-summer, here are 10 important details from the underlying industry-agency user-fee agreements that medtech firms should know.

US FDA: No Timeframe On Combo Products Council Response To Industry Feedback

Industry stakeholders are still confused about the scope of the recently formed Combination Products Policy Council. In the meantime, the council says it doesn't have a specific timeframe by which it will address the issues industry has identified as priority topics.

Companies Want New US FDA Council To Help Resolve Inter-Agency Combo Product Disputes

A range of topics were raised in feedback provided by industry groups to FDA about what the priorities should be for the agency's new Combination Products Policy Council, but addressing inter-center disagreements was a repeat concern. Also raised: misaligned communication policies; pediatric combo-product reviews; and implementation of the 21st Century Cures Act.

Related Content

Topics

UsernamePublicRestriction

Register

MT103755

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