A Slow Takeoff for FDA's Brand Name Pilot Program
This article was originally published in RPM Report
Executive Summary
FDA's pilot program for testing and approving proposed brand names is slowly beginning to gain traction-despite initial concern from drug sponsors that the new process would lead to longer review times. For early adopters, it means a chance to collaborate with FDA on what will likely become the new regulatory standard. For everyone else, it may mean being a step behind.