FDA Draft Guidance on Real-World Data (Forbes)

FORBES | In a document issued this week, the Food & Drug Administration laid out for comment its draft guidance of how real-world evidence could support regulatory decision-making for medical devices. This is a positive step forward for improving the medical product development process. At the Bipartisan Policy Center, Representative Bart Gordon and I have been urging FDA to advance medical innovation with real-world evidence. FDA has limited this guidance to how real-world evidence may be used for regulatory review of medical devices. But the FDA is to be applauded for taking this step, and acknowledging the increasingly vital role real-world data (RWD) will have in healthcare.

Read more at Forbes.