Antibiotic Exclusivity: Which Vision Will GAIN Upper Hand In FDA List-making?
This article was originally published in The Pink Sheet Daily
Industry presenters tell FDA a broad list of potential diseases will attract more developer interest, but advocacy groups push for more targeted criteria during a public hearing on the new exclusivity incentive.
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Rib-X is among the first to take advantage of the Generating Antibiotic Incentives Now provisions of the FDA reauthorization legislation with five years’ extra exclusivity for its lead broad spectrum antibiotic candidate, a next-generation fluoroquinolone. Designation for the program came swiftly, company says.
FDA and industry are turning their attention to implementation of the Generating Antibiotic Incentives Now provisions of PDUFA V, which include an additional five years of marketing exclusivity for certain products and new guidance aimed at streamlining the drug development process.