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Zdrowie i gospodarka · 10.01.2000

Draft Guidance for Industry on Photosafety Testing; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Photosafety Testing.'' The draft guidance is intended to help applicants decide whether they should test for photosensitivity and assess potential human risk for photochemical carcinogenesis (cancer) and enhancement of UV-induced skin carcinogenesis during the development of topically and systemically administered drug products. The draft guidance describes a consistent, science-based approach for considering testing. FDA is soliciting comments and seeking information from interested persons concerning photosafety testing.

Source: Federal Register — Food and Drug AdministrationOpen original release →