Table of Contents

• AboutPHUSE
  • BIMO

  Test Test Test TestTest TestTest TestTest TestTest Test

  • •  BIMO
    •  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