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  • About

    •  BIMO

    •  PHUSE BIMO FAQ Forum Project

    •  How to effectively utilize PHUSE BIMO FAQ Forum Project

    •  Acronyms used in PHUSE BIMO FAQ Forum Project

  • BIMO Submission Helpful Resources

    •  FDA portal

    •  PHUSE portal

    •  White paper [Useful and applicable]

  • BIMO Submission Standards / Guidance

    •  Standardized Format for Electronic Submission of BIMO

    •  BIMO Technical Conformance Guide (TCG)

    •  Difference between FDA CDER Vs FDA CBER BIMO submission

    •  Pre-Submission FDA Meeting Planning/Discussion

    •  BIMO Clinical Data consistency with SDTM/ADAM

    •  BDRG consistency with cSDRG/ADRG

    •  Consistency among BIMO Submission to FDA


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