# Clinical Lactation Studies: Considerations for Study Design - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/clinical-lactation-studies-considerations-for-study-design/7e2a7cd7-32ed-4962-a11a-5ece5acd2cb4

> FDA guidance document: Clinical Lactation Studies: Considerations for Study Design. Issue date: May 09, 2019. Get complete insights and analysis.

---

## Details

- Title: Clinical Lactation Studies: Considerations for Study Design
- 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: 2019-05-09
- Last Changed: 2020-05-06
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-4525. ">FDA-2018-D-4525. </a>

## Related Documents

- [Master Protocols for Drug and Biological Product Development](https://www.globalkeysolutions.net/guidances/guidance-document/master-protocols-for-drug-and-biological-product-development/401e65ec-7388-4389-a95a-dc8860a1ce51)
- [Labeling for Biosimilar and Interchangeable Biosimilar Products](https://www.globalkeysolutions.net/guidances/guidance-document/labeling-for-biosimilar-and-interchangeable-biosimilar-products/54a5f712-03f5-4993-b0d7-6a1c2f261eff)
- [Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings : Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/rare-diseases-early-drug-development-and-the-role-of-pre-ind-meetings-draft-guidance-for-industry/3c7d812a-8f9d-42ac-b54e-ad63ed389dab)
