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

 
• By Cole Werble and Laura Helbling

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.

FDA’s Office of Antimicrobial Products and Allergan PLC went one step too far for the agency’s Anti-Infective Drugs Advisory Committee on the effort to expedite an application for a new antibiotic combination product for serious, unmet needs.

Appearing as virtual cosponsors for ceftazidime/avibactam for three “unmet need” indications, FDA and Actavis succeeded in getting strong approval votes...

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More from Regulatory Trackers

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 
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Global Pharma Guidance Tracker - June 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.