Zdrowie i gospodarka · 10/09/2013

FDA Releases Draft Guidance on Generic Drug User Fee Amendments of 2012

The Food and Drug Administration (FDA) has released a draft guidance document addressing questions and concerns from the generic drug industry regarding the Generic Drug User Fee Amendments of 2012 (GDUFA). The guidance aims to clarify the requirements and commitments of GDUFA, which is designed to improve the efficiency and cost-effectiveness of generic drug development and delivery.