Zdrowie i gospodarka · 06/04/2020

FDA Publishes Report on Assessing Resource Needs for Prescription Drug and Biosimilar Review Programs

The FDA is seeking public comment on a new report that proposes a methodology to accurately assess changes in resource and capacity needs for human drug and biosimilar biologic review programs, with the goal of adjusting annual fee revenue amounts for the Prescription Drug User Fee Act and Biosimilar User Fee Act programs.