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

UsernamePublicRestriction

MDUFA V: FDA Looks For More User-Fee Investments; Industry Wants To Work With What’s There

Executive Summary

US FDA commissioner Stephen Hahn argued on 27 October that his device center should consider more user-fee investments to alleviate the agency’s workload and address new innovations – but industry wants the FDA to finish hiring and work with what’s there.

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.

US Election 2020: What Does A Trump Or Biden Win Mean For FDA Regulations?

Experts say either would likely prioritize issues such as the coronavirus pandemic and the medical supply chain, but they would diverge in areas like laboratory developed test reform.

Massive Family Dollar Rat Infestation Leads To Multi-State Recall

The US FDA found more than 2,000 rats at an Arkansas Family Dollar distribution center, leadingto a six-state recall for products including feminine hygiene products, contact lens cleaners and face masks.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT142972

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