Guidance for Industry. ANDAs: Pharmaceutical Solid Polymorphism. Chemistry, Manufacturing, and Controls Information

摘要

Chemistry, manufacturing, and controls (CMC) information must be submitted to support the approval of an abbreviated new drug application (ANDA). This guidance is intended to assist applicants with the submission of ANDAs when a drug substance exists in polymorphic forms. Specifically, this guidance provides: FDA recommendations on assessing sameness when the drug substance exists in polymorphic forms. Decision trees that provide recommendations on monitoring and controlling polymorphs in drug substances and/or drug products. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.