FDA Antibiotic Task Force Developing Standards To Help Products GAIN Traction
This article was originally published in The Pink Sheet Daily
Task force model emerging as agency’s standard approach to implementing statutory directives to enhance product development.
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Both FDA and Congress are taking interest in combating antibiotic resistance, but FDA likely has more power to make headway in the near term, even as industry remains somewhat wary of that particular agenda item.
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.
The agency is seeking comments on the criteria prescribed in FDASIA and suggestions for other standards necessary to create a list of pathogens that qualified infectious disease products should target.