Book on Regulatory Practice and Intellectual Property Now Available
Wayne, PA, February 21, 2019 – Facet Life Sciences, a leading provider of development software and services for small and growing life sciences teams, today announced the availability of a new book, “FDA and Intellectual Property Strategies for Medical Device Technologies”, in which two of Facet’s regulatory experts were contributing authors.
In the book, Lisa Jenkins VanLuvanee, Ph.D., Vice President of Research and Development at Facet Life Sciences, and Dana Blue, M.S., Product Development Champion at Facet, introduce regulatory compliance for medical devices and strategies for navigating the scientific and regulatory review process. They also offer a detailed description of the Premarket Approval (PMA) and the 510(k)-application process for medical devices.
Authors Gerald B Halt, John C. Donch, Amber R. Stiles and Brandon R. Theiss also describe unique intellectual property rights and challenges that medical device teams face and discuss their impact on the process of obtaining intellectual property protections.
Dr. Jenkins VanLuvanee commented, “We are excited that the book is now available. Regulatory approval and intellectual property processes are uniquely intertwined. Medical device technology innovators must plan for both of these complex processes in order to be successful.”
Ken VanLuvanee, President and CEO, Facet Life Sciences, commented, “FDA review processes and intellectual property protection intersect at numerous times throughout the development process. This publication takes advantage of experts in each of the fields to cover two very complex, yet important topics. We are proud of the contributions our team members made to the authoring of this book.”
About Facet Life Sciences
Facet Life Sciences is the leading provider of innovative development solutions (software and services) designed to help small teams get to and through the FDA©. Our Product Development Champions deliver expert nonclinical, CMC, and clinical regulatory services using cutting-edge technologies that speed product R&D efforts. Facet teams create and manage critical development documentation for some of the industry’s fastest growing, most innovative life sciences companies.