Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products

On 8 September 2022 the FDA published the final guidance on real-world data and real-world evidence.

To facilitate FDA’s internal tracking of submissions to the Agency that include real-world data (RWD) and real-world evidence (RWE), this guidance encourages sponsors and applicants to identify in their submission cover letters certain uses of RWD/RWE. This guidance does not address FDA’s substantive review of the RWD/RWE submitted as part of the Agency’s standard review process.

This guidance applies to submissions for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) that contain RWD/RWE intended to support a regulatory decision regarding product safety and/or effectiveness.