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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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.