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OTC antifungal testing

Executive Summary

FDA tells W. F. Young in Nov. 4 letter that T. rubrum fungal isolate must be prevalent for a clinical study of tinea pedis. "With regard to fungal isolates," FDA said, "at a minimum, a significant number of clinical cases need to be positive for T. rubrum because T. rubrum is considered one of the most common orgamisms found in tinea pedis and one of the most difficult to eradicate".
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PS009268

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