Back to: FDA Generic Drugs Forum 2025
Presenter
Onyekachukwu (Onyeka) Ihezie, PharmD
Regulatory Business Process Manager
Division of Regulatory and Business Process Management I (DRBPMI)
Office of Program and Regulatory Operations (OPRO)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Dr. Onyeka Ihezie is a Regulatory Business Process Manager within the Division of Regulatory and Business Process Management I (DRBPMI) in the Office of Program and Regulatory Operations (OPRO), Office of Pharmaceutical Quality (OPQ) at the U.S. Food and Drug Administration (FDA). Since joining the agency in September 2022, she has played a key role in optimizing regulatory review processes, ensuring efficiency, and facilitating timely decision-making within the ANDA and NDA programs.
In her current role, Onyeka collaborates with multidisciplinary teams to streamline regulatory workflows, enhance operational efficiencies, and support compliance with FDA policies and timelines. She provides strategic oversight and process improvements that help maintain the integrity and effectiveness of the pharmaceutical quality review process. By leveraging her expertise in regulatory affairs and pharmaceutical sciences, she ensures that critical deadlines are met and that the regulatory review process remains transparent and consistent.
Prior to joining the FDA, Onyeka served as an Ambulatory care pharmacist at Kaiser Permanente in Largo, MD, where she provided direct patient care, medication management, and clinical support to optimize therapeutic outcomes. She earned her Doctor of Pharmacy degree from Hampton University School of Pharmacy in 2012.
Thaoly Nguyen, PharmD
Regulatory Business Process Manager
Division of Regulatory and Business Process Management III (DRBPMIII)
Office of Program and Regulatory Operations (OPRO)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Thaoly Nguyen serves as a regulatory business process manager (RBPM) within the Office of Pharmaceutical Quality (OPQ). As a RBPM, she oversees the regulatory processes associated with the quality assessment of Abbreviated New Drug Applications. Her efforts in OPQ include implementing improvements to enhance the efficiency of regulatory processes for quality assessment activities. Prior to joining the FDA in 2022, Thaoly served as a vaccination and hormonal contraception prescribing pharmacist in Annapolis, MD, for 14 years. She received her Doctor of Pharmacy from the University of Maryland, Baltimore, in 2008 and recently completed her project management professional training with Duke University in 2024.
Abstract
Oneyeka Ihezie and Thaoly Nguyen discuss the importance of accurately completing FDA Form 356h in ANDA submissions at the Generic Drugs Forum 2025. They highlight the form’s role as the official cover document for applications, ensuring necessary information is provided for efficient review. Their presentation outlines common discrepancies found in the form, such as missing or incorrect facility details, improper categorization of establishments, and incomplete data sections. They emphasize the impact of these errors on the approval process, including delays and additional information requests. The speakers recommend using FDA guidance, cross-checking submission documents, and maintaining up-to-date facility status to avoid these issues. The session stresses that while Form 356h may seem trivial, its accuracy is critical to achieving timely ANDA approvals.