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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
The purpose of this guidance is to recommend international standards for photosafety assessment, and to harmonize such assessments that support human clinical trials and marketing authorizations for pharmaceuticals. This guidance includes factors for initiation of and triggers for additional photosafety assessment and should be read in conjunction with ICH M3(R2), section XIV(14) on Photosafety Testing (Ref. 1). It should reduce the likelihood that substantial differences in recommendations for photosafety assessment will exist among regions.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-D-0068.