FDA Issues Draft Guidance On the Use and Curation of Real-World Data in Registries

FDA Issues Draft Guidance On the Use and Curation of Real-World Data in Registries
The US Food and Drug Administration has issued draft guidance outlining the agency’s recommendations for using real-world data from (and curating such data in) registries to support regulatory decision-making. Pharmaceutical manufacturers and other life-sciences industry stakeholders, as well as registry developers, should review the guidance and consider submitting comments before the February 28, 2022, deadline.

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2021-12-11 01:15:00