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

QUOTED. 14 August 2019. Bradley Merrill Thompson.

Executive Summary

Long-delayed changes to the US FDA's approach to postmarketing safety reporting for combination products are set to come into effect in 2020, following the agency’s recent release of a final guidance document on the issue. See what Combination Products Coalition general counsel Bradley Merrill Thompson said about the guidance here.

“It appears that the FDA has addressed comments provided by industry on topics like follow-up reports, details to be included in the periodic safety reports, foreign events, same or similar devices and information-sharing responsibilities." – Bradley Merrill Thompson, general counsel, Combination Products Coalition

Click here for a free trial of Medtech Insight

 
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

MT125496

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