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.
For
Scott Vehovic
Commander, United States Public Health Service (USPHS)
Supervisory Project Manager, Division of Project Management (DPM)
Office of Regulatory Operations (ORO)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Scott Vehovic is a Supervisory Project Manager, supervising a team responsible for the regulatory management of Abbreviated New Drug Application (ANDA) generic drug approvals in the Office of Generic Drugs, USFDA. An officer with the United States Public Health Service (USPHS) for over 15 years, I’m a strong advocate of the mission and vision of the USPHS and the Food and Drug Administration, including the pharmacy profession, by supporting the availability of safe and effective generic drugs to the American public.
Abstract
At the 2025 Generic Drugs Forum, Ted Sherwood presents on behalf of Scott Vehovic, outlining efforts to improve FDA communication with companies when abbreviated new drug application (ANDA) goal dates are missed. He describes a shift from limited, vague updates to a proactive, transparent approach that includes early warnings, more precise explanations, and regularly scheduled status calls. The new pilot program enables project managers and senior FDA staff to provide tailored updates and help companies better understand delays, even before goal dates are missed. Sherwood emphasizes collaboration, secure communication, and the importance of designating authorized representatives to streamline interactions and keep applications moving forward.