Forest's Ceftaroline Data Robust Even Under New Antibiotic Efficacy Standards, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Sensitivity analyses provide a way around proposed changes in FDA's data requirements for skin infections and community-acquired bacterial pneumonia.
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Forest's Unlikely Co-Sponsor For Ceftaroline Review: FDA Steps In
FDA got a chance to show off its ability to stimulate antibiotic development during an advisory committee review of a new cephalosporin from Forest Labs. In the past, the agency has been faulted for failing to set clear targets for anti-infective trials; with ceftaroline, the agency went to the other extreme, stepping in to support an application with key re-analyses of data. Reprinted from The RPM Report, November 2010.
Forest's Unlikely Co-Sponsor For Ceftaroline Review: FDA Steps In
FDA got a chance to show off its ability to stimulate antibiotic development during an advisory committee review of a new cephalosporin from Forest Labs. In the past, the agency has been faulted for failing to set clear targets for anti-infective trials; with ceftaroline, the agency went to the other extreme, stepping in to support an application with key re-analyses of data. Reprinted from The RPM Report, November 2010.
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The new endpoint proposed in FDA’s recent acute bacterial skin and skin structure infections guidance – cessation of lesion spread – needs further refinement to be a reliable assessment of antibiotic efficacy, according to members of the agency’s Anti-Infective Drugs Advisory Committee.