Nneka Onwudiwe

PRO/PE Regulatory Review Officer


Nneka C. Onwudiwe, PhD, PharmD, MBA, is the technical expert and point of contact in the review of patient-reported outcomes (PRO), pharmacoeconomics (PE), and other type of claims in prescription drug promotion for the Division of Advertising and Promotion Review II (DAPR II) within the Office of Prescription Drug Promotion at the Food and Drug Administration (FDA). Dr. Onwudiwe received her doctorate in Pharmacy from the University of Maryland School of Pharmacy, PhD in Health Services Research with a specialization in Pharmacoeconomics from the University of Maryland School of Pharmacy, and a MBA (Honors) from the University of Baltimore. In addition, she received an honor of Rho Chi in Pharmacy in 2002 and an honor of Beta Gamma Sigma in Business Administration in 2012.

In addition to her position at the FDA, Dr. Onwudiwe teaches Comparative Effectiveness Research (CER) & Pharmacoeconomics at the University of Maryland School of Pharmacy. Dr. Onwudiwe has received several awards and has been recently nominated for a Service and Excellence Award. She has received funding as a Principal Investigator from NIH/NHLBI. Dr. Onwudiwe currently serves on the Food and Drug Law Institute (FDLI) Update Editorial Advisory Board, as well as the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Value Assessment Frameworks Stakeholder Advisory Panel.

Dr. Onwudiwe has served on several ISPOR Scientific and Health Policy Working Groups (Task Forces and Special Interest Groups) that have developed products and tools used by decision makers and researchers around the world. She is currently serving on the Value Assessment of Medical Device Special Interest Group. In addition to this work, Dr. Onwudiwe has presented at various professional conferences and published in several peer-reviewed journals such as Value in Health Regional Issues, Spine, Journal of the American Medical Association (JAMA), Obesity, Oncologist, Cancer Medicine, and Ethnicity and Disease.

Dr. Onwudiwe holds a license in pharmacy and practices as pharmacist in the community providing medication therapy management (MTM) and other services.