Can A Safety Study Support A Superiority Claim? Barely, US FDA Advisors Say
This article was originally published in SRA
Using a clinical trial originally designed for safety to support an efficacy superiority claim poses unique challenges that can make reliance upon a single study for regulatory purposes potentially risky.
You may also be interested in...
During meeting on real-world evidence, FDA’s Bob Temple describes real-world problem of patient access: his struggles to convince his insurer to cover Lilly/BI's diabetes drug Jardiance – which he helped review.
Keeping Track: Immuno-Oncologics And Abuse-Deterrent Opioids Take Center Stage (Again); Jardiance CV Claim Approved
The latest drug development news and highlights from our FDA Performance Tracker.
Keeping Track: Novartis' Ribociclib, Tesaro's Niraparib Submitted; Catalyst Clears Path For Firdapse Resubmission
In retrospect, the European Society for Medical Oncology meeting was a showcase for pivotal trial data included in a burst of targeted therapy new drug applications, and more drug development news and highlights from our FDA Performance Tracker.