FDA bolsters Real World Evidence Program with new Draft Guidance

FDA continues to develop its program to integrate Real World Evidence (RWE) into the Agency’s regulatory program. In September 2024, FDA issued Draft Guidance “Integrating Randomized Controlled Trials for Drug and Biological Productions into Routine Clinical Practice.” This Draft Guidance provides insight on the roles of sponsors, clinical investigators, and local health care providers to integrate research into routine clinical practice. This shows FDA’s continued commitment to the RWE program, and acknowledging the value of data collected through the course of routine clinical practice.