Pink Sheet 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

Final EU guidance issued on clinical evaluation of coronary stents

This article was originally published in SRA

Executive Summary

Final guidance from the European Commission on the clinical evaluation of coronary stents describes the main requirements for the clinical evaluation of this group of Class III medical devices based on current state-of-the-art and on experience drawn from the most recent reviews of clinical studies1.

You may also be interested in...



FDA To Ramp Up ASCA Pilot In 2021

A report from the US FDA says the agency will focus on updating its premarket submission portal, training staff and taking additional steps to start taking in applications for ASCA pilot participant sponsors.

Scotland's MGB Plots Phase III For Promising Antibacterial

With a late-stage compound on its hands, MGB is currently in discussions with several biotech and pharma companies and also with venture capitalists to continue late-stage development of a novel antibiotic which could transform treatment of Clostridium difficile.

AstraZeneca Vaccine May Only Gain EU Approval In Under 70s

AZ and the EU are at loggerheads over supplies of the COVID-19 vaccine. On top of that, its marketing authorization will present dilemmas.

UsernamePublicRestriction

Register

LL1135544

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