Foreign FDA pre-approval inspections: requirements/preparation.
Wells
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Rhône-Poulenc Rorer Pharmaceuticals Incorporated, Collegeville, Pennsylvania.
D017277:Drug Approval; D004345:Drug Industry / Q000379:methods / Q000592:standards*; D007391:International Cooperation; D008330:Management Audit; D014481:United States; D014486:United States Food and Drug Administration