FDA's U-Turn On Fanapt: Comparative Assessments Must Have Clinical Meaning
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
The review of Vanda’s Fanapt casts into relief the contours of FDA’s authority to consider comparative efficacy as a factor in drug approval decisions.
You may also be interested in...
Cardiac Safety Could Be Distinguishing Point For Sunovion's New Antipsychotic Latuda
Lack of a cardiac safety signal looks to be a key selling point for Sunovion Pharmaceuticals' atypical antipsychotic Latuda (lurasidone).
HRA’s Efficient Ella Development Strategy Begat FDA’s Efficient NDA Review
The story of HRA Pharma’s emergency contraceptive Ella (ulipristal) bears many of the hallmarks of what many sponsors would consider a desirable regulatory path, culminating in a first-cycle approval with clean labeling.
HRA’s Efficient Ella Development Strategy Begat FDA’s Efficient NDA Review
The story of HRA Pharma’s emergency contraceptive Ella (ulipristal) bears many of the hallmarks of what many sponsors would consider a desirable regulatory path, culminating in a first-cycle approval with clean labeling.