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FDA GUIDANCE · FINALDecember 3, 2025

QTc Information in Human Prescription Drug and Biological Product Labeling: Guidance for Industry

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status
Final
Topic
Labeling
Issue date
December 3, 2025
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