PDUFA Old School: Industry Wants User Fees To Get Back To Basics
This article was originally published in The Pink Sheet Daily
Executive Summary
User fees should be spent on improving drug assessments, not funding everybody's wish list for FDA action, Genzyme policy advisor tells DIA
You may also be interested in...
FDA’s Budget Proposal: It’s The User Fees’ Agency Now
User fees, not appropriations, will make up the bulk of FDA’s human drug spending if President Obama’s FY 2014 budget comes to pass, a trend fueled by new user fee programs and cuts to taxpayer funding.
PDUFA Negotiations Focus On Review Delays; Firms, FDA See Different Causes
Industry appears to be showing its strongest hand as PDUFA V negotiations roll along, laying down the cards showing FDA's poor record of meeting user fee goals in recent years
PDUFA Negotiations Focus On Review Delays; Firms, FDA See Different Causes
Industry appears to be showing its strongest hand as PDUFA V negotiations roll along, laying down the cards showing FDA's poor record of meeting user fee goals in recent years