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Nina Mezu-Nwaba

Food and Drug Administration, USA

Biography

Nina Mezu-Nwaba is working as a Captain with the United States Public Health Service and a Senior Compliance Officer in the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration. She has over 20 years of clinical, retail, and regulatory experience, with expert knowledge in OB/GYN, Gastroenterology, Surgical and Urology products. She has been with the FDA for 17 years and has held positions at the Office of Generic Drugs, the Center for Drug Evaluation and Research, CDRH Office of Device Evaluation, and CDRH Office of Surveillance and Biometrics. She obtained her Doctor of Pharmacy from the University of Maryland at Baltimore, a Master’s in Biomedical Science from Georgetown University and a Master’s in Public Health from the John Hopkins Bloomberg School of Public Health. She has represented the FDA in Berlin, Puerto Rico, and the US as the Liaison for International Standards Committees. She actively participates in community health outreach, mentoring, as well as international humanitarian missions. She seeks to bridge gaps in health-disparities through voluntary service with the Commissioned Corps, Health and Human Services, MI Foundation in Nigeria, Rotary Club and serving the USPHS in Indian Health Reservations and other US locations.

Abstract

Abstract : Current regulatory trends and applicability of biomarkers in drugs, biologics and devices: A US FDA Outlook