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FAQs about the FDA Guidance on the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products
Analyzing real-world data (RWD)1 to generate real-world evidence (RWE)2 is an emerging trend in the healthcare community. RWE is routinely used to evaluate a treatment’s real-world effectiveness, safety, and economic value, but it has also been increasingly leveraged in clinical trials. To promote the progression this field, FDA has published Read more…
