International Conference on Harmonisation; Guideline on Detection of Toxicity to Reproduction for Medicinal Products; Availability; Notice - [Docket No. 93D-0140]

摘要

The Food and Drug Administration (FDA) is publishing a final guideline entitled ``Guideline on Detection of Toxicity to Reproduction for Medicinal Products.'' This guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guideline is intended to reflect sound scientific principles for reproductive toxicity testing. The guideline is applicable to sponsors submitting applications to both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).