GDUFA: Review Costs Continued To Climb Once Formal Review Goals Began
Generic drug reviews during the first year of formal review goals cost 70% more than during GDUFA's inaugural year.
You may also be interested in...
Is a rush of generic applications seeking the 10-month clock on the way?
In interview with the Pink Sheet, Center for Drug Evaluation and Research director discusses her 30-year career, retirement speculation, and upcoming projects.
FDA and industry say they have reached tentative agreement, but finance subgroup says more discussion needed.