美国FDA 指导原则 风险管理计划缓解药品短缺的可能性 英文原版.pdfVIP

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美国FDA 指导原则 风险管理计划缓解药品短缺的可能性 英文原版.pdf

Risk Management Plans to Mitigate the Potential for Drug Shortages Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Lane, Rm. 106

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