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

FDA Law Blog

This memorializes a more recent practice adopted by the Agency given the increased use of WRO meetings during the COVID-19 pandemic, allowing follow-up questions to clarify the Agency’s feedback in a WRO or something captured in meeting minutes. Finally, FDA will hold a public workshop on meeting management.