Federal Register Notice: FDA is making available a draft guidance, S10 Photosafety Evaluation of Pharmaceuticals prepared under the auspices of the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. The draft guidance includes criteria for initiating and triggering additional photosafety testing and should be read in conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. Its purpose is to recommend international standards for photosafety assessment and to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals. To download this guidance, click here. To view this notice, click here.