PDUFA User Fee Assessment Guidance

FDA has published a guidance, Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022, with information for stakeholders on the agency’s implementation of PDUFA 7 changes to the user fee program. The document describes the types of user fees authorized by PDUFA 7, how FDA determines which products are subject to a user fee, and discusses FDA’s priorities on exceptions, exemptions, and waivers. It also describes the process for submitting payments to the agency, the consequences for failing to pay PDUFA fees, and the process for requesting a reconsideration of a user fee assessment.

The guidance includes an Introduction, Background, Definitions, Changes to the Structure of the PDUFA User Fee Program, Human Drug Application Fees, Prescription Drug Program Fees, Waivers of PDUFA Fees, Effect of Failure to Pay Fees, and Payment Information and Procedures.