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

FDA’s Hahn Says The Agency Is Meeting Its MDUFA Review Goals – For Now

Executive Summary

US FDA commissioner Stephen Hahn says in a 16 April communique that the agency is still performing “user-fee review activities” despite the ongoing coronavirus pandemic – but he warns that the FDA might not be able to do so “indefinitely.”

You may also be interested in...



Hahn Praises FDA Staff For Meeting User-Fee Goals While Adjusting To COVID-19

In a 23 June blog post, FDA head Stephen Hahn issued a statement praising agency staff for continuing to meet their statutory obligations under MDUFA V considering the added difficulties of working through the coronavirus pandemic. While noting the agency is being creative in how it works in its new COVID-19 reality, he cautioned the FDA may not be able to meet those deadlines in the future if things continue as they are. Hahn also in his blog post addressed in-person inspections of manufacturing facilities.

Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot

In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?

Thumbs Up: FDA Authorizes Weight Loss Suturing Systems From Apollo Endosurgery

People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT126600

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