US FDA reveals some PDUFA meeting details
This article was originally published in SRA
Executive Summary
Documents posted on the US Food and Drug Administration's website that contain summaries of meetings the agency has held with various stakeholders to discuss the reauthorisation of the Prescription Drug User Fee Act reveal that the drug industry has "agreed to include the $65 million in additional fee revenues for drug safety" in fiscal year 2012 in the base fee revenue amount for PDUFA V1.