FDA’s FY23 GDUFA for generic drugs development
The US Food and Drug Administration (FDA) yesterday released its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report.
This report aggregates metrics for regulatory and scientific outcomes, such as the number of controlled correspondences, product-specific guidances, and abbreviated new drug application (ANDA) approvals that were supported by GDUFA research. These metrics are grouped into three areas where the FY23 GDUFA Science and Research Program is expected to make an impact:
1) Supporting the pharmaceutical development of generic drug products
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