# Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act: Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/safety-labeling-changesimplementation-of-section-505o4-of-the-fdc-act-draft-guidance-for-industry/2ed7dede-8a3f-4f38-baa2-5eec541a5edb

> FDA guidance document: Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act: Draft Guidance for Industry. Issue date: September 18, 2025. Get complete insights and analysis.

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## Details

- Title: Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act: Draft Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2025-09-18
- Last Changed: 2025-09-18
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2011-D-0164">FDA-2011-D-0164</a>

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