The US Food and Drug Administration (FDA) on Thursday finalized two guidances that detail how sponsors can leverage and submit real-world data (RWD) in their new drug and biological product submissions.
One guidance sets out the agency’s criteria for converting data derived from RWD sources such as electronic health records (EHRs) to FDA-supported data standards for new drug applications (NDAs) and biologics license applications (BLAs), while the other addresses the use of registries as a source of RWD in regulatory submissions…
