Antibiotics Stewardship Remains Open Question On Capitol Hill
FDA’s role in the practice of medicine becomes an issue as IDSA’s proposal to spur antibiotic development by coupling small trials with limited use comes late to the antibiotic incentives debate on Capitol Hill.
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Achaogen has designed a registration program with a single Phase III study for its next-generation aminoglycoside, plazomicin, to treat serious infections due to carbapenem-resistant Enterobacteriaceae, in what could be an interesting test for potential modifications to the standard approval pathway.
Antibiotic Incentives: FDA’s Woodcock Says LPAD Could Be Better Than Exclusivity, But Questions Remain
Rep. Phil Gingrey, lead sponsor of the Generating Antibiotic Incentives Now Act, says industry still has questions about the proposed approval pathway for antibiotics treating life-threatening diseases, further clouding its prospects.
CDER director says SPLMU proposal could open up antibiotics for resistant pathogens to orphan drug incentives, which could help prime the anemic development pipeline.