James Mullally, Ph.D, Former U.S. Food & Drug Administration (FDA) Assistant Director of the Division of Chemistry and Toxicology Devices joins MCRA as Vice President, In-vitro Diagnostic (IVD) Regulatory Affairs.
WASHINGTON, July 15, 2021 /PRNewswire/ -- MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, and Quality Assurance, is pleased to announce James Mullally, Ph.D, Former U.S. Food and Drug Administration (FDA) Assistant Director of the Division of Chemistry and Toxicology Devices (DCTD), has joined MCRA as Vice President, IVD Regulatory Affairs.
While serving as Assistant Director of the Division of Chemistry and Toxicology Devices at FDA, Dr. Mullally managed a team of engineers, scientists, chemists, and microbiologists reviewing 510(k), de novo, IDE, PMA, 513(g), breakthrough designations, and other submission types for a diverse IVD portfolio including companion diagnostic (CDx), therapeutic drug monitoring (TDM), genetic, and women’s health IVDs, as well as devices supported by point of care (POC), over the counter (OTC), or CLIA waiver studies.
Recently, as part of FDA’s response to the pandemic, he volunteered to be reassigned to the Division of Microbiology Devices (DMD), and there led a team reviewing COVID-19 serology device Emergency Use Authorizations (EUAs). He previously served as a scientific reviewer in DCTD, where he conducted reviews of premarket and postmarket submissions (e.g. continuous glucose monitoring (CGM) and other diabetes devices), and also served as the division’s instrument and software product specialist.
Dr. Mullally specializes in FDA interactions and strategy, development of regulatory submissions, medical and regulatory writing, review and analysis of pre-clinical and clinical data, design of clinical trials, regulatory review of marketing materials, and regulatory strategy for IVD medical devices.
Dr. Mullally served on several senior-level working groups, including the companion diagnostics working group, where he provided input on companion diagnostic device review policy at FDA. He was also the FDA representative for the SAMHSA Drug Testing Advisory Board, serving as a board member.
Glenn Stiegman, MCRA’s Senior Vice President, Clinical and Regulatory Affairs said “As we expand further into in vitro diagnostics, we wanted to hire someone with the necessary leadership and expertise to tackle some of the most novel IVDs being developed, and Dr. Mullally provides that leadership and experience. Dr. Mullally’s extensive time at the FDA has provided him with a deep understanding of not only how to efficiently accomplish IVD validation for a wide array of device technologies and intended uses, but also how to navigate the regulatory process through effective strategies and market success. This experience will be extremely valuable for MCRA’s IVD clients that need guidance and support with their regulatory strategy and submissions”.
Dr. Mullally said “I expect my role at MCRA to be rewarding because it will give me the opportunity to use my skill-set to overcome the challenges that MCRA’s IVD clients face, saving them critical time and financial resources so that they can achieve timely delivery of their device to the market, and ultimately provide patients with improved medical care and better outcomes.”
About MCRA, LLC: MCRA is the leading privately held independent medical device and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its clients industry experience at integrating five business value creators: regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance to provide a dynamic, market-leading effort from concept to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, and New York, NY, and serves more than 700 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, general surgery, digital health, neurology, robotics, and in vitro diagnostic (IVD) devices as well as medical device cybersecurity. www.mcra.com
About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specializes in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. www.vbllc.com
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