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


Emergency Clinical Trial Guidance Offers A Peak At The Future Of Virtual Trials: Expert

Executive Summary

The current pandemic has accelerated the US FDA’s perspective on conducting remote clinical trials. The agency has published an emergency guidance to allow sponsors to continue their work, which a former FDA official says is an indication of where the agency is headed post-COVID-19.

You may also be interested in...

Human Factors Experts Forge Ahead With ‘Tricky’ In-Person Studies In The Age Of Coronavirus

Sanofi usability expert Molly Story and other longtime human factors professionals detail some extraordinary measures they’re taking to keep study participants and moderators safe, from the simple (masking up) to the more extreme (using separated testing rooms). Also: the US FDA weighs in on remote testing.

There’s No Need To Include Off-Label Use In Labeling, FDA Says In Proposed Rule

After concerns from the medtech industry that a 2017 final rule requires sponsors with knowledge of off-label use of their product to add it to their label, the US FDA is proposing to delete the confusing text.

COVID-19 Shows Remote Monitoring Can Work For Pre-Cert Program

In an update to stakeholders, the US FDA says regulators can successfully evaluate a firm’s performance, allowing it to eventually get medical software to market in the agency’s Pre-Cert Program.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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