Draft Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Drug Substance: Chemistry, Manufacturing, and Controls Information." This draft guidance provides recommendations on the chemistry, manufacturing, and controls (CMC) information for drug substances that should be submitted to support original new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 The draft guidance is structured to facilitate the preparation of applications submitted in Common Technical Document (CTD) format.