The Food and Drug Administration Office of Compliance's Role in the Preapproval Process

Abstract

FDA's preapproval inspection program focuses on the integration of field efforts in support of the Center for Drug Evaluation and Research's (CDER) approval of NDAs and ANDAs. Preapproval inspections complement the scientific review of safety and efficacy conducted by CDER's scientists, by evaluating GMPs and the validity of the NDA/ANDA being reviewed by CDER. CDER's Office of Compliance, and in particular the Division of Manufacturing and Product Quality, plays a key role in that process to ensure the safety, efficacy, and quality of drug products that are approved.