美国FDA 指导原则 ICH Q12实施FDA监管产品的考虑因素行业指南草案 英文原版.pdfVIP

ICH Q12: Implementation Considerations for FDA-Regulated Products Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to . Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers