美国FDA 指导原则 根据GDUFA行业指南草案,FDA和ANDA申请者之间的产品特定指导会议 英文原版.pdfVIP

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美国FDA 指导原则 根据GDUFA行业指南草案,FDA和ANDA申请者之间的产品特定指导会议 英文原版.pdf

Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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),

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