Antibiotics Could Get Double Exclusivity Under House Bill; FDA Makes Its Own Moves
Five years of additional exclusivity, priority review and fast-track status are the carrots offered in legislation introduced by Rep. Phil Gingrey, R.-Ga., June 15 to entice drug makers to develop antimicrobials for drug-resistant pathogens.
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Orphan Antibiotics? Woodcock Says It May Be Possible If IDSA’s New Pathway Is Implemented
CDER director says SPLMU proposal could open up antibiotics for resistant pathogens to orphan drug incentives, which could help prime the anemic development pipeline.
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.
PDUFA Draft Bill Would Broaden FDA’s Mission, Make Guidance Development More Public
FDA would be tasked with protecting public health while promoting economic growth and job creation under a discussion draft from the House authorizing committee. Draft Guidances would be voided if not finalized within a year under the proposal.