ABSTRACT
Medical device approval demonstrated the emergence of Real World Evidence (RWE) as a potentially transformative new tool in personalized medical care and drug development and regulation. RWE can provide the information which informs precision medicine decisions. The Precision Medicine Committee examines legal issues affecting the rapidly emerging field of precision medicine. Precision medicine utilizes information on an individual’s genetics and biomarkers, and environmental and lifestyle factors, to inform decisions on disease prevention and treatment. Used appropriately, RWE could advance medical and regulatory science in many respects, in both pre-approval and post-approval contexts. Pre-approval RWE could supplement randomized clinical trials, reducing the time and costs of drug and device development. The Agency hoped to create incentives for systematically collecting and organizing information from routine use of devices in medical care by expressing a willingness to consider RWE in its regulatory decisions.
