# Study of Sex Differences in the Clinical Evaluation of Medical Products - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/study-of-sex-differences-in-the-clinical-evaluation-of-medical-products/d77c04e8-ef7b-4fbb-8b73-5fe6d3a9117f

> FDA guidance document: Study of Sex Differences in the Clinical Evaluation of Medical Products. Issue date: December 15, 2025. Get complete insights and analysis.

---

## Details

- Title: Study of Sex Differences in the Clinical Evaluation of Medical Products
- 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: 2025-12-15
- Last Changed: 2025-12-15
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2024-D-4245">FDA-2024-D-4245</a>

## Related Documents

- [Drug Master Files Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/drug-master-files-guidance-for-industry/7dfd5140-3156-43f2-bdb9-d23ad597311c)
- [Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/gluten-in-drug-products-and-associated-labeling-recommendations-draft-guidance-for-industry/7c089d7c-0cae-4796-899d-09c5a25a376f)
- [Postapproval Changes to Drug Substances Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/postapproval-changes-to-drug-substances-guidance-for-industry/78d470cd-b4c0-45be-b582-1163b9b97017)
