The US Food and Drug Administration (FDA) published a final guidance last week that updates the agency’s user fee structure and other aspects of the Generic Drug User Fee Amendments (GDUFA III) deal that was passed last year. The guidance provides the rationale for how regulators assessed how much to charge for various user fees.
FDA published the latest GDUFA assessment for FY 2023 on 8 June. The document details changes to the user fee structure and more specifically it explains the new generic user fee structure, such as those for abbreviated new drug applications (ANDA), and the types of fees for which sponsors are responsible. The user fee structures laid out in the document went into effect at the start of FY 2023 (1 October 2022)…
