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Del Pharmaceuticals

This article was originally published in The Tan Sheet

Executive Summary

Asks FDA to clarify suggestions on Del's proposed clinical study to support the efficacy of Auro-Dri. FDA asked that the study be conducted in subjects with a history of swimmer's ear and that a no treatment control be used in the study ("The Tan Sheet" Dec. 13, 1993, p. 5). In the letter, Del questioned the necessity of testing individuals with a history of swimmer's ear since Auro- Dri is indicated to help dry water-clogged ears and not for the prevention of swimmer's ear

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