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

PMA Review Times Increased After User Fee Initiation, Study Affirms

This article was originally published in The Gray Sheet

Executive Summary

Researchers sought to investigate the impact on market access of several health-care “modernization” laws enacted in the past 15 years, finding that legislative efforts have not improved FDA or CMS review efficiency for devices.

You may also be interested in...



Device Industry Expects Quicker Path To Market In Exchange For Doubling Of User Fees

The tentative agreement of $595 million in user fees over five years is more than companies had wanted to spend. But industry negotiators insist it is a good deal, tied to performance goals and process improvements they say will ensure greater speed and predictability in reaching the U.S. market.

Calling All Innovators: FDA And CMS Seek Candidates For Parallel Review Pilot

FDA and CMS are seeking device companies with innovative technologies to participate in the first test of "parallel," or simultaneous, pre-market approval and Medicare coverage reviews.

Biogen Value-Based Contract Links Patient-Reported Outcomes To MS Drug Reimbursement

Biogen value-based contract with UPMC Health Plan ties payments to patient-reported outcomes for Tecfidera and Avonex. The company may seek something similar for Vumerity.

Topics

UsernamePublicRestriction

Register

MT031656

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