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

Source: https://www.keypedia.com/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.

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## 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>

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