ARTICLE | Top Story

PDUFA V deal done

May 27, 2011 12:32 AM UTC

BIO and PhRMA have reached a final agreement with FDA on terms for reauthorizing PDUFA, according to sources involved with the negotiations. The final element of the deal, language committing FDA to "promoting innovation through enhanced communication" with sponsors during drug development, was agreed upon this week. Previously agreed elements of PDUFA V include two-month extensions on standard and priority PDUFA review goals, and user fee funding for 119 new FDA staff for regulatory science projects. The five-year PDUFA V cost is expected to be about $3 billion, up from about $2.8 billion for PDUFA IV.

FDA has agreed to adopt a "philosophy statement" committing the agency to "timely interactive communications with sponsors during drug development." A PDUFA V goals letter commits FDA to develop, by the end of FY13, a dedicated staff to liaise with sponsors during the IND process and to train CDER staff on best practices for enhanced communication with sponsors. ...