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Two Steps Forward, One Step Back: FDA, Actavis Antibiotic Plan Goes A Bit Too Far For Committee

This article was originally published in RPM Report

Executive Summary

FDA continues to reshape the antibiotic regulatory pathway, both in word and in deed. The latest example of a collaborative, push-the-envelope review included a novel Actavis antibiotic formulation where FDA seemed ready to approve the drug without any human data. That was one step too far for the agency’s advisors.

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