Antibiotic Development Incentives Face Critical Test As NDA Reviews Begin
Law has encouraged FDA to be flexible on data requirements for antibiotics, according to sponsors.
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With a Special Protocol Agreement and an experienced sales team lined up, all the firm has to do now is get hospitals excited about an expensive antibiotic in a highly-genericized market.
Goal of 10 new antibiotics by 2020 may be unlikely given current marketplace for antibiotics, some experts predict as a new study shows recent proposals to revive development may be focused at wrong point in development timeline. Study suggests need for large increases in government funding.
Durata has post-marketing requirements to continue resistance-related studies, but its label includes stewardship language similar to other antibiotics.