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 guidance for industry 169 entitled "Drug Substance Chemistry, Manufacturing, and Controls Information." This guidance provides recommendations on the chemistry, manufacturing, and controls (CMC) information for drug substances that should be submitted to support original new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs). The guidance is structured to facilitate the preparation of applications submitted in Common Technical Document (CTD) format.