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Real World Data and Real World Evidence to Support Regulatory Decision Making for Drug and Biological Products – FDA Draft Guidance

  1. FDA regulations under part 312 outline procedures and requirements governing the use of investigational new drugs, including the requirements for an IND submission to and review by the FDA.
  2. FDA recognizes the potential utility of using RWD in interventional studies; for example, to identify potential participants for a randomized controlled trial, to ascertain endpoints or outcomes (e.g., the occurrence of stroke or other discrete events, hospitalization, survival) in a randomized controlled trial, or to serve as a comparator arm in an externally controlled trial, including historically controlled trials.
  3. Non-interventional studies analyze data reflecting the use of a marketed drug administered in routine medical practice, according to a medical provider’s clinical judgment and based on patient characteristics, rather than the assignment of a participant to a study arm according to a research protocol.