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Zdrowie i gospodarka · 21/03/2024

FDA Releases Draft Guidance on Real-World Evidence for Non-Interventional Studies of Drug and Biological Products

The FDA is releasing a draft guidance on the use of non-interventional studies, also known as observational studies, to demonstrate the effectiveness and safety of pharmaceutical products, as part of its Real-World Evidence (RWE) Program.

Source: Federal Register — Food and Drug AdministrationOpen original release →