FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Flag Real-World Evidence in IND Applications, FDA Says

May 14, 2019
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Sponsors planning to use real-world evidence in drug development must identify the sources of that evidence when requesting an IND from the FDA.

IND cover letters should indicate whether a sponsor hopes to use real-world evidence to support the safety or efficacy of a drug, to change a drug’s label, or to comply with a postmarketing requirement, the agency says in a draft guidance released last week.

The guidance draws a line between real-world data—information about patients’ health status or healthcare delivery “routinely collected from a variety of sources,” including electronic health records, medical claims or billing data—and clinical evidence for a drug from analysis of real-world data.

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