美国FDA 指导原则 参考上市药品上市申请被撤回后ANDA标签的更新 英文原版.pdfVIP

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美国FDA 指导原则 参考上市药品上市申请被撤回后ANDA标签的更新 英文原版.pdf

Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Division of Dockets Management (HFA-3

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