EMA: New Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products:   http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/11/WC500216158.pdf   FDA: New Guidance for Industry on the Assessment of Male-Mediated Developmental Risk for Pharmaceuticals:   https://www.federalregister.gov/documents/2015/06/12/2015-14363/assessment-of-male-mediated-developmental-risk-for-pharmaceuticals-draft-guidance-for-industry