Accelerated And Accompanied: Oncology Drugs Should Use Randomized Trials, FDA Panel Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Single-arm studies for accelerated approval should be used only when the patient population is small or drug activity is high, the Oncology Drugs Advisory Committee says.
You may also be interested in...
Farydak Confirmatory Trial To Come Years After Accelerated Approval
Despite the agency’s preference that confirmatory trials generally be under way at the time of accelerated approval, Novartis’ panobinostat Phase III trial isn’t expected to begin for approximately three years.
FDA Often Looks Outside The Application, Review Documents Show
A look back at drug reviews in the past year illustrates the many ways FDA takes external factors into consideration when reviewing an application – from guiding trials to look for certain class safety signals to finding support for a particular endpoint.
FDA Often Looks Outside The Application, Review Documents Show
A look back at the past year of Pharmaceutical Approvals Monthly’s Drug Review Profile series illustrates the many ways FDA takes external factors into consideration when reviewing an application – from guiding trials to look for certain class safety signals to finding support for a particular endpoint.