Incorporating Real-World Evidence In the Approval Processes

HMP Global December 5, 2022
Mary Beth Nierengarten

Health care stakeholders, including regulatory bodies and payers, are increasingly incorporating real-world evidence into their approval processes, prompting the need for formal guidance.

In 2021, the Food and Drug Administration (FDA) issued 4 draft guidances on the use of real-world data (RWD) and real-world evidence (RWE) to inform regulatory decision-making on the safety and effectiveness of drugs and biologics. The guidance cover issues related to data sources, data standard, and regulatory considerations. The FDA defines RWD and RWE as follows:

• RWD: data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources; examples include electronic health records, claims/billing, product/disease registries, patient-generated data, data gathered from other sources such as mobile devices.
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