FDA finalizes guidance on RWD from electronic health records
Regulatory News | 25 July 2024 | Ferdous Al-Faruque FDA headquarters in White Oak, MD. (Source: Ferdous Al-Faruque) The US Food and Drug Administration (FDA) has finalized its guidance on evaluating real-world data (RWD) from electronic health records (EHR). The final guidance offers additional clarification on selecting study variables and validation and includes recommendations…