Back to: FDA Generic Drugs Forum 2025
Presenter
Nuri Tawwab, PharmD, MPH
Lieutenant Commander, United States Public Health Service (USPHS)
Stakeholder Engagement Team
Division of Prevention Communication and Public Engagement (DPCPE)
Center for Substance Abuse Prevention (CSAP)
Substance Abuse and Mental Health Services Administration (SAMHSA)
United States Food and Drug Administration (FDA)
LCDR Nuri Tawwab is a Senior Regulatory Business Process Manager at the U.S. Food and Drug Administration (FDA) with extensive expertise in drug regulation, generic drug approval processes, and the implementation of the Generic Drug User Fee Amendments (GDUFA). With a career spanning over a decade in pharmaceutical quality and regulatory affairs, LCDR Tawwab plays a pivotal role in ensuring the timely approval of generic drugs while maintaining compliance with congressionally mandated guidelines.
In their current role within the Office of Pharmaceutical Quality at the FDA’s Center for Drug Evaluation and Research (CDER), LCDR Tawwab manages the lifecycle of over 100 generic medications and oversees teams of chemistry and biology drug reviewers to facilitate the approval of Abbreviated New Drug Applications (ANDAs). Their leadership in GDUFA III implementation and process optimization has contributed to enhanced efficiency, improved stakeholder engagement, and substantial cost savings for both the agency and the public.
Recognized for their contributions to regulatory excellence, LCDR Tawwab has successfully expedited high-priority drug approvals, coordinated international industry meetings to streamline regulatory processes, and provided strategic oversight to enhance review timelines. Their expertise in regulatory affairs, stakeholder communication, and program management uniquely positions them to deliver a comprehensive and insightful presentation on GDUFA III and its impact on drug regulation at the FDA.
Abstract
At the 2025 Generic Drugs Forum, Lieutenant Commander Nuri Tawwab presents an overview of his role as a Regulatory Business Process Manager (RBPM) in the FDA’s Office of Pharmaceutical Quality. He explains how RBPMs coordinate communication between the FDA and drug firms, manage reviewer assignments, and oversee the life cycle of generic drug applications under the GDUFA program. Tawwab outlines tools like Panorama and Mercado that support workload tracking, goal date monitoring, and internal deadlines, ensuring timely and efficient reviews. He highlights key enhancements under GDUFA III, including revised timelines, expanded control correspondence, and strategies to reduce the number of review cycles. Tawwab also shares best practices for effective meeting management, stakeholder communication, and documentation, emphasizing the importance of structure, accountability, and collaboration in the regulatory review process.