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 provisions in section 503(g) of the Federal Food and Drug Cosmetic Act (FD&C Act).
The question-and-answer guidance includes background information on combination products, how the agency determines user fees for single applications and two applications, and information on requesting user fee waivers or reductions of user fees…
