美国FDA 指导原则 根据《联邦食品、药品和化妆品法》第510(J)(3)条申报上市药品和生物制品的数量；行业指南草案 英文原版.pdfVIP

Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FDC Act Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Ad