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# Drug Development Testicular Toxicity Guide
- URL: https://www.fdaweb.com/drug-development-testicular-toxicity-guide/
- Published: 2018-10-25T12:00:00.000Z
- Updated: 2026-09-15T00:40:39.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142670

*Federal Register* notice: FDA has made available a guidance entitled “Testicular Toxicity: Evaluation During Drug Development.” The document addresses nonclinical findings that may raise concerns of a drug-related adverse effect on the testes, clinical monitoring of adverse testicular effects early in clinical development, and the design and conduct of a safety clinical trial assessing drug-related testicular toxicity. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-10-25/pdf/2018-23304.pdf?ref=fdaweb.com).