THE FUTURE OF ELECTRONIC SUBMISSIONS
DISCUSSION TOPICS
NEXT STEPS:
NEXT STEPS: (con’t)
IMPLEMENTATION AND EVALUATION OF AERS
IMPLEMENTATION AND EVALUATION OF AERS (con’t)
IMPLEMENTATION: ELECTRONIC CRFs and CRTs
IMPLEMENTATION: ELECTRONIC CRFs AND CRTs (con’t)
FURTHER DEVLOPMENT: Bioequivalence Study Submission
FURTHER DEVLOPMENT: Bioequivalence Study Submission (con’t)
FURTHER DEVLOPMENT: Package Insert
EARLY DEVELOPMENT:
FUTURE DIRECTIONS:
KEY FACTORS:
PARADIGM
PPT Slide
ELECTRONIC NDA FILINGS
ELECTRONIC SUBMISSIONS AND DRUG DEVELOPMENT
WILL IT DRIVE CHANGE?
AVAILABILITY OF CLINICAL TRIAL DATASETS
SUMMARY
Home Page: http://www.fda.gov/cder/present/diamontreal/