Yun Lu

Yun Lu

Company: FDA, CBER

Job title: Mathematical Statistician, Office of Biostatistics and Pharmacovigilance


Regulatory Considerations for the Use of Real World Evidence (RWE) to Support Post-marketing & Pre-approval for Drug & Biological Products 11:30 am

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 submissionsRead more

day: Day One

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