Healthcare Economist September 24, 2023
Last month, FDA released guidance on the use of real-world evidence to support regulatory decision-making for new drugs. Below are some of the key points from this guidance document:
- Legislative mandate. The 21st Century Cures Act (Cures Act), signed December 2016, mandated that the FDA consider how to incorporate real world data (RWD) into regulator decisionmaking. The guidance issues addresses part 312 (Investigational New Drug Application)
- Types of real-world data. FDA defines RWD as “…data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” RWD sources explicitly named in the guidance include “registries, electronic health records (EHRs), and medical claims.” Questionnaires, laboratory tests, and imaging studies that are part...
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