Abstract
Over-the-counter (OTC) switches are assessed differently throughout the review divisions of the Food and Drug Administration (FDA). This paper presents the approach taken by the Pilot Drug Evaluation Staff. The three types of OTC switches: complete, partial, and lower effective dose, as well as approaches to efficacy, safety, and usage trials will be described in detail. Any switch consideration, moreover, takes into account a weight-of-the-evidence, case-by-case approach, based on prior knowledge gained from the current marketing experience with the drug, with specific regard to safety and efficacy.
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