The Next PDUFA: New Performance and Procedural Goals

Friday, July 15, 2016

Source: RAPS

Exactly one year after the first round of negotiations over the sixth iteration of the Prescription Drug User Fee Act (PDUFA), the US Food and Drug Administration (FDA) on Friday released the full details of the performance and procedural goals for fiscal years 2018 through 2022.

The 46-page document, which outlines how the agency will use the user fees provided to it from industry, breaks down not only the planned deadlines for new guidance documents and pilot projects, but also highlights recurring themes of recent importance, including on patient input to the regulatory process, use of real-world evidence, biomarker qualification and increased pharmacovigilance.

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