Applying RWD: Use Cases And FDA Guidance

This presentation, featuring experts from Exact Sciences, Johns Hopkins University, and Flatiron Health, delves into pragmatic approaches for clinical evidence generation and regulatory acceptance. It examines recent FDA draft guidance on integrating Real-World Data (RWD) and Real-World Evidence (RWE) in medical device studies, offering practical research strategies. The session also presents case studies of companies effectively leveraging RWE, showcasing alignment with regulatory guidance and facilitating acceptance.