Table of Contents

• 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