FY 2024 Real-World Evidence Statistics Out

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 (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).