Draft Guidance for Industry on Drug Product: Chemistry, Manufacturing, and Controls Information; Availability

Resumen

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Drug Product: Chemistry, Manufacturing, and Controls Information." This draft guidance provides recommendations on the chemistry, manufacturing, and controls (CMC) information for drug products that should be submitted in original new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The draft guidance is structured to facilitate the preparation of applications submitted in Common Technical Document (CTD) format.