Introduction

Welcome to Protocol Link's first newsletter of 2017!  We hope everyone had a wonderful holiday season and are enjoying the start of the new year.

This first edition of 2017 has some great articles to keep you up to date with current industry news and updates, including an exploration into the process of combination product reviews, a look at two new final guidance document releases related to benefit-risk, and an examination of FDA's partnership with Academic Medical Centers.

Noteworthy Links
Combination Product Reviews - An Evolving Process
Christine Shumard-Sauer, Ph.D, Director

The review of combination product premarket submissions poses unique challenges, both because the products may involve new, complex technologies, and because their review at FDA often involves the expertise of more than one center. In response to these challenges, in 2015 the FDA published a Combination Products Review titled, "The Intercenter Consult Process Study", which was the result of focus groups from Center reviewers and input from industry. As a result of issues identified in this report, the Agency made several commitments to modernize the combination product review program.

Two New Device "Benefit-Risk" Guidance Documents
Laura Spiegelhoff, Manager

On December 27, 2016, a Final Guidance document entitled Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions; Guidance for Industry and Food and Drug Administrative Staff was issued. This Guidance document defines FDA's current approach to benefit-risk principles to be utilized by the device industry during device design assessments, responses to nonconforming product or regulatory issues.

FDA's Partnership with the Academic Medical Centers
Lokesh Kukreja, Ph.D, Senior Scientist

In a recent message to the public, FDA Commissioner Dr. Robert M. Califf emphasized the importance of strengthening the relationship that exists between the nation's academic medical centers (AMCs) and the FDA. In the modern era of medicine, AMCs have become multi-billion dollar medical systems. From FDA's perspective, nurturing partnerships with AMCs will play an important role in the development of innovated solutions to modern health care challenges that can ultimately benefit the American public.

A Word From Our Staff...
Hard to believe another year has slipped away! Seems like only a short time ago we were looking back at 2015 and now we have 2016 to look back upon with 2017 just beginning.

2016 was especially unique from a global perspective as we were able to contribute and share in the success of so many of our clients in both the US and the rest of world. In the past year, our team was busy across a broad spectrum of services, supporting our client's growth in areas of mergers and acquisitions, maintenance and expansions of quality enhancing programs including quality system building, combined with the ongoing management of regulatory compliance to meet the best standards of our industry in all business areas. On top of that, our home town Chicago Cubs winning the World Series for the first time since 1908 made this past year one of the more memorable.

I am so happy to let you all know how special you are to us, especially at this special time of the year. We wish you all the best, and may your New Year bring health, happiness and success!

We look forward to working closely with you in the upcoming year.

Dipak Doshi
Chief Executive Officer