# S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals : Guidance for Industry - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/s5r3-detection-of-reproductive-and-developmental-toxicity-for-human-pharmaceuticals-guidance-for-industry/b68debd9-c581-404c-b7fd-963716474af6 > FDA guidance document: S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals : Guidance for Industry. Issue date: May 11, 2021. Get complete insights and analysis. --- ## Details - Title: S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals : Guidance for Industry - Communication Type: Guidance Document - Product Type: biologics - Office Name: Center for Drug Evaluation and Research - Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c - Issue Date: 2021-05-11 - Last Changed: 2021-05-11 - Docket Number: FDA-2017-D-5138 ## Related Documents - [M9 Biopharmaceutics Classification System-Based Biowaivers](https://www.globalkeysolutions.net/guidances/guidance-document/m9-biopharmaceutics-classification-system-based-biowaivers/bf9d33a6-a7bf-4b4e-bf7a-2a88d1e6d1cf) - [S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals : International Council for Harmonisation; Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/s11-nonclinical-safety-testing-in-support-of-development-of-pediatric-pharmaceuticals-international-council-for-harmonisation-draft-guidance-for-industry/fced35c3-d5e6-4841-8ff6-57b97393063c) - [Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry: Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/q12-technical-and-regulatory-considerations-for-pharmaceutical-product-lifecycle-management-guidance-for-industry-guidance-for-industry/3d2c4a48-664c-46f3-8af1-d21c9b7858a3)