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Zdrowie i gospodarka · 10.05.2019

Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations." This guidance represents FDA's current thinking on the conduct of in vivo absorption trials for topically applied active ingredients that are under consideration for inclusion in an over-the- counter (OTC) monograph.

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