Leveraging Real World Evidence in Regulatory Submissions

Results of an analysis of different types of regulatory submissions supported by RWE.

If your email program has trouble displaying this email, view as a webpage. FDA Leverages Real World Evidence Today, the U.S. Food and Drug Administration (FDA) released the results of a recent analysis illustrating the wide range of real-world evidence (RWE) the Agency has leveraged to help make regulatory decisions related to medical devices. The benefits of using RWE include: Bringing new products to the market. Evaluating the safety and effectiveness of existing products for new uses. Assessing the continued performance of products once on the market. Advances in the availability of real-world data (RWD) sources—such as electronic health records, registries, medical claims, pharmacy data and feedback from wearables and mobile technology—have increased the potential to generate robust RWE to support the FDA's regulatory decisions for medical devices, such as automatic external defibrillators (AED) and mobile software application for contraception, to name a few. Read More Questions? If you have questions, contact the Division of Industry and Consumer Education.

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