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

‘Never Again’: Shuren Talks COVID-19 Lessons At FDA Small Business Event

Executive Summary

Despite insisting that he would never want to relive the stressful days of 2020, US FDA device center chief Jeff Shuren said the pandemic nevertheless led to improvements in regulatory flexibility and communication with industry.

You may also be interested in...



EUAs Pose Single Largest Health Technology Risk, Safety Group Says

The organization ECRI cited emergency use authorized products as the biggest risk in a new report, saying the temporary clearances aren’t built to ensure lasting safety.

CDC To Yank EUA On Original COVID-19 Test At Year’s End

The US body says it wants to encourage labs to use newer, faster alternatives that can also detect other pathogens.

MDUFA V: Industry, FDA Tangle Over TAP Program, Agency Finances, Reinstatement Of Fifth-Year Offset Funds

In newly published meeting minutes, industry and the US FDA continued to clash over a proposal to create a new pre-submission advisory program and what to do with carryover user-fee funds.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT144239

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