What Does ODEI Stand For?

ODEI stands for Office Of Drug Evaluation I CDER

The Office of Drug Evaluation I (ODEI) is a division within the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). ODEI is responsible for the evaluation and regulation of prescription drug products, guiding them through the approval process to ensure their safety, efficacy, and quality for public use. The office plays a critical role in assessing clinical data, overseeing labeling practices, and providing regulatory guidance to stakeholders, thereby contributing to the development of innovative therapies that meet the needs of patients.