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.

The FDA user fee law may end up serving as a catalyst not only for the development of new antibiotics, but also for the agency’s revamping of its drug approval processes for anti-infective drugs.

A mix of new incentives specifically geared for antibiotics, such as additional marketing exclusivity and guidance on streamlining the drug...

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