Tracking PDUFA V: Making a good thing better
This article was originally published in SRA
Executive Summary
Negotiations for the fifth round of the Prescription Drug User Fee Act (PDUFA V) went unprecedentedly smoothly. Nevertheless, the trade groups representing the biopharmaceutical industry are looking to make a good thing better, introducing of a new tracking system aimed at ensuring drug makers have sustained engagement with the Food and Drug Administration throughout the drug application review process.