FDA Clarifies Real-World Data Requirements for Drug Sponsors

Manufacturers that file new drug applications must consider the reliability of data sources and consult with privacy experts when gathering evidence outside of traditional clinical trial settings, the Food and Drug Administration said in draft guidance released Thursday.

The document, which has not yet been finalized by the agency, includes the latest in a series of recommendations issued by the FDA as it works to help drug and biologic sponsors incorporate real-world data within drug applications seeking agency approval. Real-world data includes information related to a patient’s health status or the delivery of health care, such as data from ...