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FDA Guidance Provides Road Map for Use of Real-World Data and Evidence

The new FDA guidance on the use of real-world data (RWD) and real-world evidence (RWE) is a long-anticipated playbook for how a drug manufacturer can employ a non-interventional study for regulatory decision-making. The process is not as simple as extracting observational data from a registry, although the benefits are potentially immense given that the sponsor can avoid the need for an expensive and cumbersome randomized controlled clinical trial (RCT).