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CDER Photosafety Guidance for Industry

Center for Drug Evaluation and Research/U.S. Food and Drug Administration (CDER/FDA), Rockville, Maryland 20857, USA, jacobsa{at}cder.fda.gov

Paul C. Brown

Center for Drug Evaluation and Research/U.S. Food and Drug Administration (CDER/FDA), Rockville, Maryland 20857, USA

Conrad Chen

Center for Drug Evaluation and Research/U.S. Food and Drug Administration (CDER/FDA), Rockville, Maryland 20857, USA

Amy Ellis

Center for Drug Evaluation and Research/U.S. Food and Drug Administration (CDER/FDA), Rockville, Maryland 20857, USA

James Farrelly

Center for Drug Evaluation and Research/U.S. Food and Drug Administration (CDER/FDA), Rockville, Maryland 20857, USA

Robert Osterberg

Center for Drug Evaluation and Research/U.S. Food and Drug Administration (CDER/FDA), Rockville, Maryland 20857, USA

In the Federal Register of January 10, 2000 (65 FR 1399), FDA published a draft guidance entitled "Photosafety Testing." The notice gave interested persons an opportunity to submit comments. As a result of the comments, certain sections of the guidance were reworded to improve clarity. A final guidance was published in May 2003. The final guidance further emphasizes that a flexible approach can be used to address adverse photoeffects and that specific assays are not required. Moreover, it encourages the development of methods that can efficiently be used to evaluate human safety. The guidance describes a consistent, science-based approach for testing of topically and systemically administered drug products.

Key Words: Photoirritation • photosensitivity • CDER guidance.

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