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

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