Back to: FDA Generic Drugs Forum 2025
Presenter
Kendra S. Stewart, RPh, PharmD
Captain, United States Public Health Service (USPHS)
Deputy Director for Operations, Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Captain Kendra Stewart is the Deputy Director of Operations for the Office of Generic Drugs (OGD) whereby she oversees the scientific and regulatory operations. Captain Stewart received her Doctor of Pharmacy degree from the School of Pharmacy at Florida A&M University and completed her clinical pharmacy residency at the James A. Haley Veterans Affairs (VA) hospital in Tampa, FL. She’s a lifelong public servant and has devoted her career of over 23 years to various scientific and managerial roles in the federal government specializing in the areas of health informatics, drug policy and regulatory operation.
Abstract
Captain Kendra Stewart, Deputy Director for Operations at the Office of Generic Drugs (OGD), delivers closing remarks at the 2025 Generic Drugs Forum by thanking presenters, participants, and the SBIA team for a successful and informative event. She emphasizes the forum’s objectives—to enhance regulatory knowledge, streamline the ANDA assessment process, and reduce review cycles—while highlighting OGD’s commitment to public health through modernization, efficiency, and innovation. Stewart recaps key topics discussed, such as labeling, DMFs, nitrosamines, and the Orange Book, and encourages attendees to explore OGD’s new resource page for additional tools and training. She underscores the critical role of collaboration in ensuring access to safe, effective, and affordable generic drugs, noting that generics account for over 90% of U.S. prescriptions and save the healthcare system more than $1 billion daily. Stewart concludes by calling for continued momentum and partnership in advancing generic drug development and access.