Medtech Insight is part of the Business Intelligence Division 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

"Standard" Coronary Stent Trials Should Use PMA Data From Past Trials

This article was originally published in The Gray Sheet

Executive Summary

Coronary stent manufacturers with products already approved by FDA might consider releasing data contained in their premarket approval applications to serve as a replacement for the control arm for certain coronary stent trials, provided firms receive some level of compensation for the data and a certain amount of control over how they are used.
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT011083

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

Cancel