Back to: FDA Generic Drugs Forum 2025
Presenter
Edward (Ted) Sherwood
Director, Office of Regulatory Operations (ORO)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Edward (Ted) Sherwood has been the Director of the Office of Regulatory Operations (ORO) within the Office of Generic Drugs (OGD) since 2014. ORO consists of three divisions: Division of Project Management, Division of Filing Review, and Division of Labeling Review. Previously, he served as the Associate Director of Immediate Office Operations, Office of Pharmaceutical Science [now the Office of Pharmaceutical Quality (OPQ)]. Prior to joining OPQ in 1999, he spent a dozen years in OGD. He held various positions including, reviewing new submissions for determination of fileability, conducting program analyses, and coordinating congressional activities. Edward received his bachelor’s degree from the University of Maryland in 1992.
Abstract
At the 2025 Generic Drugs Forum, Ted Sherwood addresses the issue of missed goal dates for abbreviated new drug applications (ANDAs). He emphasizes that while only a small number of applications are affected, each miss is taken seriously by the FDA. Sherwood explains the internal processes aimed at preventing these delays, including cross-disciplinary coordination, early application tracking, and a command center for oversight. He distinguishes between goal date completion and approval, clarifying that the goal is a complete agency decision by the set date. He also highlights contributing factors such as inspection delays, data integrity issues, and late applicant submissions. Despite any setbacks, Sherwood assures that the FDA never stops working on applications and remains committed to providing timely, thorough decisions that advance high-quality generic drug access.