Skipping Past Congress: Limited Use For AZ/Actavis Antibiotic Gets FDA Review
This article was originally published in The Pink Sheet Daily
Dec. 5 advisory panel for AstraZeneca/Actavis’ gram-negative antibiotic should shed light on how FDA envisions limited-use pathway requirements and labeling might work; FDA officials maintain the agency doesn’t need LPAD legislation to approve limited use antibiotics.
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