The Food and Drug Administration plans to exploit claims, clinical and patient-generated data—information not captured through traditional clinical trials—for post-marketing safety surveillance.
“New streams of real-world data gathered from electronic health records, lab tests, wearable devices, insurance claims and even social media can provide important evidence on product safety and effectiveness in settings or populations that may be very different than the information gleaned from registration trials that are used for FDA approval of medical products,” said Commissioner Scott Gottlieb, MD, during a keynote presentation on Monday at the Bipartisan Policy Center in Washington.
