"Pharmaceutical Preparations Manufacture Laws & regulations." . . . . "Legislation, Drug." . . "Technology, Pharmaceutical legislation & jurisprudence." . . "Industrie pharmaceutique Qualité Contrôle États-Unis." . . "Médicaments Normes États-Unis Guides, manuels, etc." . . . . . . . . . . . . "Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances"@en . "Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances" . . . . . . . . . . . . "Investigational New Drug Application." . . "Center for Drugs and Biologics (É.-U.)" . . "Good manufacturing practices." . . "New drug applications." . . "Médicaments Droit États-Unis Guides, manuels, etc." . .