Home » Final Guidance on PDUFA VI Explains Changes to Structure and Fee Types
Final Guidance on PDUFA VI Explains Changes to Structure and Fee Types
Drugs Regulatory Affairs
The FDA finalized guidance on assessing user fees under PDUFA VI — covering fiscal years 2018 through 2022 — describing the new fee structure and the types of fees organizations are responsible for under the act.
The guidance discusses certain changes to FDA’s policies under the new law enacted on Aug. 18, 2017 but does not deal with how the agency sets fees for each fiscal year.
The legislation eliminated fees for supplements and establishments, as well as the establishment fee special rule that applied to establishments that manufacture positron emission tomography drugs.