26 June 2024 - As part of the reauthorisation of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymised information on submissions to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research that contain real world evidence.

The tables describe submissions to the Center for Biologics Evaluation and Research containing real world evidence that meet reporting criteria. This report is not intended to include all submissions to the Center for Biologics Evaluation and Research containing analyses of real world data. Columns will be added annually to represent submissions by fiscal year from fiscal years 2023 through 2027.

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