PDUFA Negotiations Begin With FDA Seeking Review System Reform
This article was originally published in The Tan Sheet
Executive Summary
During the inaugural negotiating session for renewal of PDUFA, which covers OTC switch and other nonprescription product NDAs, FDA says among its goals are “enhancements to the review processes.” The five-hour session included the ground rules for the talks and FDA and industry representatives also laid out their general wants and needs.
You may also be interested in...
PDUFA VI: BIO Survey Finds FDA Communication Problems
Data may help industry stake out its negotiating position as formal talks near for user fee reauthorization.
PDUFA Budgeting: What Will Get Added, Subtracted – Or Multiplied By Cures?
Industry official sees potential for some streamlining in user fee program, but adding to breakthrough and patient-centered activities seems most likely.
PDUFA VI: Price Tag For Patient Experience Data Validation May Go Up
FDA wants to advance PRO projects through the user fee reauthorization, but ironically is having difficulty quantifying how much support it might need.