美国FDA 指导原则 产品质量评估的效益-风险考量 英文原版.pdfVIP

Benefit-Risk Considerations for Product Quality Assessments Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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