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Forest Labs Had Effective "Co-Sponsor" for Ceftaroline Review

This article was originally published in RPM Report

Executive Summary

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.

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Antibiotic Development: Where Wall Street Guidance Is Watching FDA Guidances

FDA’s effort to create a clearer path for antibiotic development has produced a series of new guidance documents. Those guidances are making some products in development look well-positioned for regulatory review, and rekindling the interest on Wall Street in specialty antibiotic firms.

Antibiotic Development: Where Wall Street Guidance Is Watching FDA Guidances

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