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Real-World Evidence | FDA

fda.gov · 620 words · saved by 1 readers

The .gov means it’s official.Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. FDA has a long history of using what we currently call real-world data (RWD) and real-world evidence (RWE) to monitor and evaluate the postmarket safety of approved drugs. RWE has also been used historically to support effectiveness, but on a more limited basis. Advances in the availability and analysis of RWD have increased the potential for generating robust RWE to support FDA regulatory decisions. FDA is committed to realizing the full potential of fit-for-purpose RWD to generate RWE that will advance the development of therapeutic products and strengthen regulatory oversight of medical products across their lifecycle. Real-world data are data relating to

FDA has a long history of using what we currently call real-world data (RWD) and real-world evidence (RWE) to monitor and evaluate the postmarket safety of approved drugs. RWE has also been used historically to support effectiveness, but on a more limited basis. Advances in the availability and analysis of RWD have increased the potential for generating robust RWE to support FDA regulatory decisions. FDA is committed to realizing the full potential of fit-for-purpose RWD to generate RWE that will advance the development of therapeutic products and strengthen regulatory oversight of medical pro

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