Tracking PDUFA V: Making a good thing better
This article was originally published in Scrip
Even though the negotiations for the fifth round of the Prescription Drug User Fee Act (PDUFA V) went unprecedentedly smooth, the trade groups representing the biopharmaceutical industry are looking to make a good thing better, with the introduction of a new tracking system aimed at ensuring drug makers have sustained engagement with the FDA throughout the drug application review process.
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