Putting Substance In “Substantial Evidence”: FDA Standards Take Center Stage In Rejection of Gepirone
This article was originally published in RPM Report
Executive Summary
Fabre-Kramer is asking FDA to reconsider its depression drug gepirone, nearly a decade after the agency rejected the application for the third time. The sponsor's case appears to be based on the hope that today's FDA will take a different view than the 2007 version of the agency.