Real-World Evidence Should Be Flagged In US Drug And Biologic Applications

08 May 2019

FDA will track RWE submissions under INDs, NDAs or BLAs and wants sponsors to use a simple, uniform format to identify real-world data sources and evidence generated from that data in such filings.

US FDA wants sponsors to clearly identify when an application contains real-world evidence. • Source: Shutterstock

New drug or biologic application sponsors should specify the purpose of any real-world evidence submitted with their filing, as well as the real-word data sources used to generate that evidence, the US Food and Drug Administration said in a draft guidance document released 8 May.

The agency’s drugs and biologics centers will use this information to track certain types of real-world evidence (RWE) submissions under...