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FDA Letter On Menveo News Release Offers Cautions On Launch Of Expanded Indication

This article was originally published in The Pink Sheet Daily

Executive Summary

Issued at almost the same time as Novartis submitted an sBLA for vaccination of younger children, FDA's advertising citation criticizes the pacing of an audio news release.

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Regulatory News, In Brief

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drugs to treat mild skin conditions such as impetigo and minor cutaneous abscesses, FDA says in a long-awaited draft guidance released Aug. 26.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

Regulatory News, In Brief

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drugs to treat mild skin conditions such as impetigo and minor cutaneous abscesses, FDA says in a long-awaited draft guidance released Aug. 26.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

Novartis Wins FDA Approval For Its First Meningitis Vaccine As ACIP Is Set To Meet

The vaccine targets four serotypes, but not the strain that causes the most cases among infants and toddlers, which is the most lucrative market.

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