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

FDA’s Gottlieb: Any FDA/CMS Collaboration Efforts Should Occur Postmarket

This article was originally published in The Gray Sheet

Executive Summary

FDA and CMS should streamline their internal review processes before pursuing collaborative efforts to avoid an overly burdensome review process, according to FDA Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb, MD

You may also be interested in...



Will FDA/CMS Parallel Review Idea Make Headway This Time?

The possibility of simultaneous FDA and CMS evaluations of new devices is back in the front of agency officials' minds after a series of fits and starts over the past several years, says CMS Chief Medical Officer Barry Straube

Will FDA/CMS Parallel Review Idea Make Headway This Time?

The possibility of simultaneous FDA and CMS evaluations of new devices is back in the front of agency officials' minds after a series of fits and starts over the past several years, says CMS Chief Medical Officer Barry Straube

In Rare Move, CMS Cites FDA Warning Letter In National Coverage Request

CMS' internally-generated national coverage request for infrared therapy devices uncharacteristically refers to a recent FDA warning letter to manufacturer Anodyne Therapy

Related Content

UsernamePublicRestriction

Register

MT022998

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