Zdrowie i gospodarka · 17/10/2024

FDA Announces Final Guidance for Reconsideration Requests Under GDUFA

The Food and Drug Administration (FDA) has released a final guidance for industry on procedures for requesting reconsideration of abbreviated new drug applications (ANDAs) at the division level or original signatory authority, reflecting the most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA III).