FDA Issues Draft Guidance on the Use and Curation of Real-World Data in Registries | McDermott Will & Emery
The US Food and Drug Administration has issued draft guidance outlining the agency’s recommendations for using real-world data from (and curating such data in) registries to support...
Product Development To Support Labeling Drug Administration Mcdermott Will Real World Data Assessing Registries Support Regulatory Decision Making
Source: jdsupra.com