Real-World Evidence Submission Guidance

FDA has published a draft guidance, Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drugs and Biologics, to encourage sponsors and applicants who are using real-world data to generate real-world evidence (RWE) as part of their regulatory submission to provide certain information to FDA so the agency can internally track the submissions. The document says that exploring the potential for RWE to inform regulatory decisions is mandated by the 21^st Century Cures Act.

“To inform FDA’s RWE program under the Cures Act and to help FDA understand the scope and use of RWE submitted to support regulatory decisions regarding safety and/or effectiveness, CDER and CBER intend to identify and track certain types of submissions using RWE under an IND, NDA, or BLA,” FDA says. “The draft guidance provides instructions on how to document that the submission uses RWE, including a sample presentation to include in a cover letter.”