FDA Publishes Final Guideline on Reproductive Toxicity Detection for Medicinal Products

Summary

The Food and Drug Administration (FDA) is publishing a final guideline on detecting reproductive toxicity in medicinal products, developed under the International Conference on Harmonisation (ICH), to ensure sound scientific principles for testing. The guideline applies to applications submitted to the FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).