# QTc Information in Human Prescription Drug and Biological Product Labeling:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/qtc-information-in-human-prescription-drug-and-biological-product-labeling-guidance-for-industry/84e1bfb1-3a7d-4f4f-ad99-9da85ee92408

> FDA guidance document: QTc Information in Human Prescription Drug and Biological Product Labeling:  Guidance for Industry. Issue date: December 03, 2025. Get complete insights and analysis.

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## Details

- Title: QTc Information in Human Prescription Drug and Biological Product Labeling:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Office of the Commissioner
- Office URL: /offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424
- Issue Date: 2025-12-03
- Comment Close Date: 2023-10-10
- Last Changed: 2025-12-02
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-2439">FDA-2023-D-2439</a>

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