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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

Notable Dates and Timelines – Program opens, beginning of FY 2023; Expediting reviews fully implemented, by FY 2024; Webpage with detailed criteria for acceptance and participation, October 1, 2022; Interim assessment, end of FY 2025; Public workshop, end of Q2 FY 2026. Notable Dates and Timelines – Inspection tools draft guidance, by Sept.