June 24, 2022: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH)
Rethinking Clinical Trials
JUNE 29, 2022
Center for Drug Evaluation and Research (CDER). Food and Drug Administration (FDA). With the 21st Century Cures Act of 2016, the FDA established a program to evaluate the potential use of real-world evidence to support new indications for drugs and satisfy post-approval study requirements. John Concato, MD, MS, MPH. Key Points.
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