Zdrowie i gospodarka · 09/12/2021

FDA Releases Draft Guidance on Using Real-World Data to Support Drug Regulatory Decisions

The US Food and Drug Administration (FDA) has published a draft guidance outlining the use of real-world data and real-world evidence to support regulatory decisions for drug and biological products, as part of its Real-World Evidence (RWE) Program and to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act).