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FDA guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests.
FDA has released guidance recommending international standards for photosafety assessment. The guidance harmonizes photosafety assessments that support human clinical trials and marketing authorizations for pharmaceuticals. The 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.
The guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests. It also provides strategies for determining how to assess photosafety for drugs. FDA states, “Consideration should be given to the use of non-animal methods or clinical data for photosafety assessment, which could reduce the use of animals in accordance with the 3R (replacement/reduction/refinement) principles.”
The guidance applies to new APIs, new excipients, clinical formulations for dermal application (including dermal patches), and photodynamic therapy products. FDA believes the guidance will “reduce the likelihood that substantial differences in recommendations for photosafety assessment will exist among regions.”