New drug applications; drug master files. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is revising its regulation governing drug master files (DMF's). FDA is removing the provision for submitting Type I DMF's and will no longer permit information submitted in a Type I DMF to be incorporated by reference in investigational new drug applications (IND's), new drug applications (NDA's), abbreviated new drug applications (ANDA's), or amendments or supplements to any of these. This rule is intended to eliminate submissions of information that are not necessary either to conduct inspections of manufacturing facilities or to review the chemistry, manufacturing, and controls sections of IND's, NDA's, and abbreviated applications.
D004282:Documentation; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D011996:Records; D014481:United States; D014486:United States Food and Drug Administration