Regulatory Considerations for the Use of Real World Evidence (RWE) to Support Post-marketing & Pre-approval for Drug & Biological Products

Time: 11:30 am
day: Day One


  • Real world evidence (RWE) has been increasingly utilized to help support approval of new indication of a medical product that has been approved or to help support post-approval study requirements
  • This talk will address regulatory considerations and applications of FDA Guidelines to RWE related submissions