Zdrowie i gospodarka · 13/05/2019

FDA to Hold Public Meeting on Prescription Drug User Fee Act and Biosimilar User Fee Act Efficiency and Transparency

The Food and Drug Administration (FDA) is hosting a public meeting to discuss the financial transparency and efficiency of the Prescription Drug User Fee Act (PDUFA) VI, Biosimilar User Fee Act (BsUFA) II, and Generic Drug User Fee Amendments (GDUFA) II, and to gather public comments on the agency's progress and plans for implementing these user fee acts.