GAIN Hearing Will Help FDA Set Pathogen List
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
Task force model emerging as agency’s standard approach to implementing statutory directives to enhance product development.
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.