FDA Proposes Updates for Generic Drug User Fee Amendments (GDUFA IV)

The U.S. Food and Drug Administration (FDA) has published proposed updates for the Generic Drug User Fee Amendments (GDUFA IV) in the Federal Register. These updates include adding newly identified inactive ingredients to labeling, transitioning from maximum potency to maximum daily exposure information in the Inactive Ingredient Database (IID), and establishing a public Maximum Daily Dose (MDD) database for reference listed drugs. These changes aim to enhance the efficiency and transparency of generic drug development and review processes.