USA – FDA issues final guidance user fees for combination products

The US Food and Drug Administration (FDA) on Tuesday finalized guidance for sponsors explaining how it assesses user fees for combination products and the different programs available to sponsors for requesting user fee waivers under the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Amendments (MDUFA) programs. The update replaces a final guidance issued in April 2005 to make it more consistent with current user fee programs and to reflect combination product provisi...