This title provides a useful how-to guide for practioners in the pharmaceutical industry who are navigating the FDA regulations for new drugs. Its coverage allows the user to develop the documentation needed to support changes before, during, and after the approval process, and provides recommended reporting categories. Topics such as documenting the drug substance, the drug product, analytical methodology, stability and methods of validation, container and closure systems, biologics, the drug master file, and scale-up and postapproval changes are addressed.