Chemistry, Manufacturing and Controls ( CMC )

Abstract This article describes general expectations and issues related to the Quality (also known as Chemistry, Manufacturing and Controls) section of Investigational New Drug (IND) (see Investigational New Drug Application (IND) article) applications filed with the U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) (see CDER article). Only brief mention will be made to FDA's Center for Biologics Evaluation and Research (CBER) (see CBER article) and other regulatory authorities (see Ministry of Health and Welfare (Japan, now known as the MHLW), Medicines Control Agency (United Kingdom, now known as the MHRA), and EMEA (European Union) articles). For determining whether INDs are required for clinical studies, see the Investigational New Drug Application (IND) article.