You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 16 Next »

  • 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


  • No labels