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
UsernamePublicRestriction

Exciting but uncertain times for medtech regulation

This article was originally published in Clinica

Executive Summary

Jeffrey Shuren really shouldn't have implied that the regulatory system for medical devices in the EU allowed patients to be used as guinea pigs. But that's just what the head of the US Food and Drug Administration's device centre did. Dr Shuren then also went on to argue that – despite there being "some very basic differences between the two systems that confound comparisons" – the US system was more robust than the EU system in ensuring that patients receive safe and effective products.

You may also be interested in...



COVID-19 Vaccine 'Brexit Bonus' A Myth

The Pink Sheet explains the procedures underpinning the UK’s emergency use authorization of the Pfizer/BioNTech COVID-19 vaccine.

Piqray - What EU Regulators Saw And What They Wanted

The European public assessment report for Novartis's advanced breast cancer therapy, Piqray (alpelisib), includes some interesting insights into what EU regulators are looking for in drug company clinical trials. 

AZ Will Sideline ‘Lucky Mistake’ Data To Secure COVID-19 Vaccine Approval

A lower first dose boosted the vaccine’s efficacy result, but AstraZeneca has conceded that this has to be proven in a separate trial. In the meantime, the UK government has asked the regulator to assess the vaccine under a special health emergency provision.

Topics

UsernamePublicRestriction

Register

SC143420

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