Generic Drugs
Page 1 • 2 itemsAccess critical intelligence on global generic drug market dynamics, regulatory hurdles, and competitive strategies for pharma BD and investment.
FDA Generic Drug User Fee Amendments (GDUFA) Program Updates Fee Structure and Payment Methods for 2024
FDA updates Generic Drug User Fee Amendments program with new fee structures and payment methods, impacting generic drug manufacturers and approval timelines.
FDA Begins Preparation for GDUFA IV Reauthorization: Generic Drug User Fee Program 2028-2032
FDA initiates preparation for GDUFA IV reauthorization covering fiscal years 2028-2032, setting stage for next phase of generic drug user fee program.