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Table of Contents

  • About
      • BIMO

      Test Test Test TestTest TestTest TestTest TestTest Test

        •  BIMO
        •  PHUSE
        PHUSE
        • BIMO FAQ Forum Project
        How
        •  How to effectively utilize PHUSE BIMO FAQ Forum Project
        Acronyms
        •  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