Draft Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Substances; Chemistry, Manufacturing, and Controls Information; Availability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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "ANDAs: Impurities in Drug Substances; Chemistry, Manufacturing, and Controls Information." This draft guidance provides recommendations on what chemistry, manufacturing, and controls information to include regarding the reporting, identification, and qualification of impurities in drug substances produced by chemical synthesis when submitting documentation for an abbreviated new drug application (ANDA), drug master file (DMF), or a supplement to support changes in drug substance synthesis or process.