Given their critical role in medicines, excipients were the focus of a workshop held by USP and the U.S. Food and Drug Administration (FDA) in February 2017.
This workshop focused primarily on the role of excipients in medicines, but it is important to note that excipients are key components of foods, household products, and dietary supplements. As such, the information shared in the presentations and breakout sessions has far-reaching implications for a broad range of products.
Watch Sample Video: “Safety Assessments for Excipients in Generic Drugs: A Regulatory Perspective” Sruthi King, Ph.D., Pharmacology/Toxicology Team Leader, Division of Clinical Review, Office of Generic Drugs, CDER, U.S. FDA
Excipients in generic drug products are evaluated from clinical and nonclinical perspectives to ensure that they do not alter the safety profile of the formulation, as compared to the Reference Listed Drug. This presentation outlines the process FDA uses for Pharmacology/Toxicology Review of the proposed level of an excipient. This review includes an evaluation of toxicology data to support the dose, route of administration, duration of exposure, and patient population. To see all available videos from this workshop, please click the button below.