Gottlieb lays out real world evidence priorities for 2019 with an eye on digital tools
Stressing the need for speed and efficiency, FDA Commissioner Scott Gottlieb on Monday offered a look at FDA’s plans around real-world data (RWD) and real-world evidence (RWE) in 2019.
The speech at the Bipartisan Policy Center built off a framework, released in December, that sought to begin the conversation on how RWD and RWE can support changes to labeling, including adding or modifying an indication, changes in dose, dose regimen or route of administration; changing or adding new populations; or the addition of comparative effectiveness or safety information.
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