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GDF2026 - Prioritization Requests: Prioritizing Original and Supplemental ANDAs

U.S. Food and Drug Administration (presentation) ยท July 30, 2026

FDA presenters Bailey Larson and Commander Andrew Kim reviewed criteria and processes for requesting priority review of original and supplemental ANDAs, detailed common mistakes, and described a new onshoring prioritization pilot for U.S.-based manufacturing.

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