With GAIN In Place, Antibiotic Improvements Depend On FDA Implementation
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.
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With only two weeks left in 2014, Cubist grabs another FDA approval for an antibiotic, this time to treat Gram-negative infections.