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Regulatory News, In Brief

Executive Summary

FDA advice on antibiotic development for skin infections: Non-inferiority trials are not appropriate for studying antibacterial drugs to treat mild skin conditions such as impetigo and minor cutaneous abscesses, FDA says in a long-awaited draft guidance released Aug. 26. In recommending that only placebo- or active-controlled superiority studies be employed for these conditions, the agency followed the November 2008 recommendations of its Anti-Infective Drugs Advisory Committee (1"The Pink Sheet," Nov. 24, 2008). The document, which updates a 1998 guidance, adopts new nomenclature for skin infections, eschewing the terms complicated and uncomplicated skin and skin structure infections for acute bacterial SSSI and milder skin infections. ABSSSIs include cellulitis/erysipelas, wound infections, major cutaneous abscesses and burn infections. Non-inferiority trials, as well as superiority trials, are acceptable for ABSSSIs

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