# Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act: Draft Guidance for Industry – FDA Guidance

Source: https://www.keypedia.com/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 FDA guidance document: Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act: Draft Guidance for Industry.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.

---

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- Title: Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act: Draft Guidance for Industry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

## Related Documents

- [Risk Management Plans to Mitigate the Potential for Drug Shortages](https://www.keypedia.com/guidances/guidance-document/risk-management-plans-to-mitigate-the-potential-for-drug-shortages/bd27fc63-0c90-4718-abd5-2b5af99e540e)
- [Early Alzheimer’s Disease: Developing Drugs for Treatment](https://www.keypedia.com/guidances/guidance-document/early-alzheimers-disease-developing-drugs-for-treatment/ef0ff9a7-7208-4951-acbb-acb9937f83e7)
- [Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials](https://www.keypedia.com/guidances/guidance-document/pregnant-women-scientific-and-ethical-considerations-for-inclusion-in-clinical-trials/674ff9d8-e752-4113-b7fd-bc85b7646bd3)