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Flexibility Or Formal Pathway? Avycaz Suggests FDA Doesn't Need Congress To Expedite Limited Use Antibiotics

Executive Summary

FDA steered Actavis' antibiotic Avycaz to approval for limited use based on limited data through the 505(b)(2) pathway, helped along by the agency's regulatory flexibility for medically important agents – making the Limited Population Antibiotic Development pathway under discussion on Capitol Hill look redundant.

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