WASHINGTON, D.C - For more than two decades, Dr. Janine E. Janosky, Dean of the College of Education, Health, and Human Services at U-M Dearborn, has served on Advisory Panels for the Food and Drug Administration (FDA), primarily in medical devices.
Dr. Janosky serves on the Medical Devices Advisory Committee (MDAC), focusing on areas from dental products to orthopedics. According to the Committee charter, MDAC reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation.
The Committee is made up of 18 panels. Currently, Dr. Janosky serves on the Medical Devices Dispute Resolution Panel. This panel provides advice on complex scientific issues between the Food and Drug Administration and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by the FDA, and Agency guidance and policies.
Dean Janine Janosky |
Through her work on MDAC, Dr. Janosky has contributed to the review and advisory recommendations to FDA on the approval of medical devices as well as provided guidance to industry and FDA on a number of scientific issues.
U-M faculty and staff who are serving on a Federal Advisory Committee live out U-M's mission to serve the state, nation, and world by applying their knowledge and expertise to help shape and inform national policy.
Full Biography:
Dr. Janosky is an expert in achieving impactful health initiatives and in implementing higher education programs and initiatives. Previously, Dr. Janosky served as the Vice President and lead of the Center for Clinical and Community Health Improvement at Austen BioInnovation Institute in Akron (ABIA). Through her leadership, a national model focused upon public-private-philanthropic partnerships was developed and implemented, and named an Accountable Care Community. Her work was recognized in Forbes and earned her a United States White House Champion of Change recognition as well as a number of other state and national awards. Also, Janine served as the Vice Provost for Research at Central Michigan University (CMU) where she led the effort to facilitate research opportunities, administer intellectual property activities, direct university commercialization endeavors and technology transfer activities, and develop innovative educational programs.
Prior to joining CMU, Dr. Janosky served in a number of academic and administrative roles at the University of Pittsburgh School of Medicine. These included serving as the Executive Director of the University of Pittsburgh School Of Medicine’s Center for Primary Care Community-Based Research, an entity she envisioned and created. Janine holds a doctorate from the University of Pittsburgh, a master’s from Marshall University, and a bachelor’s from Duquesne University. Janine serves in a number of board leadership roles including the Dispute Resolution Panel for Medical Devices, the Food and Drug Administration, ATHENA International, Unified, and many more. She has authored or co-authored more than 175 biomedical peer-reviewed publications, published a scholarly book, been recognized through numerous awards, and has secured as a Principal Investigator or as a Co-Investigator on more than 50 federally-funded grants and contracts.
No comments:
Post a Comment