World of Compliance Module

Introduction

The Office of Compliance (OC) in the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) ensures that drug manufacturers produce drug products in compliance with regulations, adhering to good manufacturing practices (GMPs) based on good science and robust design. These responsibilities are met primarily through the development and implementation of compliance inspection programs and by providing guidance to industry on FDA expectations and regulatory requirements.