# Evaluation of Sex Differences in Clinical Investigations:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/information-sheet/evaluation-of-sex-differences-in-clinical-investigations-guidance-for-industry/92c2b117-2251-40a9-9086-3ebfed65505e

> FDA guidance document: Evaluation of Sex Differences in Clinical Investigations:  Guidance for Industry. Issue date: January 20, 2025. Get complete insights and analysis.

---

## Details

- Title: Evaluation of Sex Differences in Clinical Investigations:  Guidance for Industry
- Communication Type: Information Sheet
- Product Type: biologics
- Office Name: Office of the Commissioner
- Office URL: /offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424
- Issue Date: 2025-01-20
- Last Changed: 2025-02-05
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-S-0610 ">FDA-2013-S-0610 </a>

## Related Documents

- [FDA Institutional Review Board Inspections:  Guidance For IRBs, Clinical Investigators, and Sponsors](https://www.globalkeysolutions.net/guidances/information-sheet/fda-institutional-review-board-inspections-guidance-for-irbs-clinical-investigators-and-sponsors/9ff5e55d-57b2-4daf-860d-a115f7c000b9)
- [FDA Inspections of Clinical Investigators:  Guidance For IRBs, Clinical Investigators, and Sponsors](https://www.globalkeysolutions.net/guidances/information-sheet/fda-inspections-of-clinical-investigators-guidance-for-irbs-clinical-investigators-and-sponsors/592d1927-3441-4de6-a968-71ff4dd6c420)
- [Civil Money Penalties Relating to the ClinicalTrialsgov Data Bank:  Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/civil-money-penalties-relating-to-the-clinicaltrialsgov-data-bank-guidance-for-responsible-parties-submitters-of-certain-applications-and-submissions-to-fda-and-fda-staff/0e9dc583-3ef6-4205-9302-de301840b935)