Real-World Evidence Submissions to the Center for Biologics Evaluation and Research & the Center for Drug Evaluation and Research

https://www.fda.gov/science-research/real-world-evidence/real-world-evidence-submissions-center-biologics-evaluation-and-research-center-drug-evaluation-and?utm_medium=email&utm_source=govdelivery Today, the U.S. Food and Drug Administration posted a public report on submissions to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) that contain real-world evidence (RWE). The use of real-world data (RWD) to improve the efficiency of drug and biologic development programs that rely on traditional clinical trials is well established and encouraged by FDA. This is the first annual report describing submissions to CBER and CDER that contain analyses of RWD to generate RWE intended to support regulatory decision-making about a drug or biological product’s effectiveness or safety. The report meets an agency commitment under the Prescription Drug User Fee Act (PDUFA VII).