In Vivo 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

Parallel FDA/CMS Review Is Poised for Prime Time - But Is Anybody Biting?

Executive Summary

The device industry has long complained about the lengthy, separate review times required to achieve FDA and CMS clearance. Finally, the two agencies are working together on a pilot program to make this process faster and more efficient. Industry's response: not so fast. Despite the apparent advantages parallel review can offer to product companies, industry has been cautious and slow to respond out of concern for protecting proprietary data and the possible need for more complex clinical studies. Parallel review may represent an example of regulators being ahead of industry in streamlining the regulatory process, and the burden will be on FDA and CMS to demonstrate the true value of this approach.

You may also be interested in...



FDA-CMS Parallel Review Saves Time, Clinical Trial Costs, Participant Says

Exact Sciences, one of the first companies to volunteer for a pilot program launched in 2011 testing FDA-CMS parallel review, says its experience with the process so far is very positive. Agency officials are planning to review experiences with the program to make improvements.

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

J&J: Getting Paid Up-Front for New Technology

The story of the successful development by Cordis Corp., a Johnson & Johnson operating company, of the first drug-eluting stent, the Cypher, and its introduction this year into the US market has been well chronicled. What is not as well known is the equally successful and ground-breaking work that Cordis did in obtaining incremental reimbursement (an increase over the existing reimbursement level for bare metal coronary stents) for the Cypher stent from Medicare prior to the device receiving FDA approval. This is an interview with the person who directed Cordis' reimbursement efforts for the Cypher stent, Brian Firth, MD, PhD, VP for medical affairs and health economics, who explains how Cordis developed and implemented its reimbursement strategy for Cypher, and the implications of this approach for future new technologies.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

IV003595

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