# E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials: Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/e21-inclusion-of-pregnant-and-breastfeeding-women-in-clinical-trials-draft-guidance-for-industry/d8ff86c3-7344-41eb-b6eb-88c5a122c46f

> FDA guidance document: E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials: Draft Guidance for Industry. Issue date: July 21, 2025. Get complete insights and analysis.

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## Details

- Title: E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials: Draft Guidance for Industry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: 2025-07-21
- Comment Close Date: 2025-09-19
- Last Changed: 2025-07-22
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2025-D-1797">FDA-2025-D-1797</a>

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