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# FY 2024 Real-World Evidence Statistics Out
- URL: https://www.fdaweb.com/fy-2024-real-world-evidence-statistics-out/
- Published: 2025-06-11T12:00:00.000Z
- Updated: 2026-09-14T15:14:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159340

FDA has published reports on the real-world evidence submissions to CBER and CDER in FY 2024, as required under the PDUFA VII reauthorization. The summary [report](https://www.fda.gov/science-research/real-world-evidence/real-world-evidence-submissions-center-biologics-evaluation-and-research-center-drug-evaluation-and?utm%5Fmedium=email&utm%5Fsource=govdelivery) (includes links to the CBER and CDER statistics pages) says the reporting intends to describe submissions to FDA containing real-world data to generate real-world evidence to support or that supported regulatory decision-making about a drug or biological product’s effectiveness or safety.

The CBER-specific report shows it received 15 protocol submissions in FY 2024, up from four in FY 2023\. It also received two NDA/BLA submissions (up from zero), and five final study reports to satisfy a postmarketing requirement or commitment (up from zero).

The CDER-specific report shows 11 protocol submissions in FY 2024 (up from 10 in FY 2023), 1 NDA/BLA submission (down from four), and five final study reports satisfying a postmarketing requirement or commitment (FY 2023 data not available).