From the Federal Register Docket No. FDA-2017-D-5138
The Food and Drug Administration (FDA or Agency) has announced the availability of a draft guidance entitled “S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals.” The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance replaces the existing guidance entitled “S5(R2) Detection of Toxicity to Reproduction for Human Pharmaceuticals.” The draft guidance is intended to align with other ICH guidances, elaborate on concepts to consider when designing studies, and identify potential circumstances in which a risk assessment can be made based on preliminary studies. It also clarifies the qualification and potential use of alternative assays.
Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 12, 2018.
The Teratology Society Public Affairs Committee will be drafting a set of Society comments for consideration by Council. Individual members are also encouraged to submit comments on the draft guidance. For information on how to do so, please visit Federal Register Docket No. FDA-2017-D-5138.