Draft Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information." This draft guidance provides recommendations on what chemistry, manufacturing, and controls information sponsors should include regarding reporting, identification, qualification, and setting acceptance criteria for impurities that are classified as degradation products in drug products when submitting an abbreviated new drug application (ANDA) or supplement to support changes in drug substance synthesis or process, formulation of the drug product, the manufacturing process, or components of the container/closure system.