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GUIDANCE DOCUMENT

S10 Photosafety Evaluation of Pharmaceuticals January 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-D-0068
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center 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.

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All written comments should be identified with this document's docket number: FDA-2013-D-0068.

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