FDA published a final guidance intended to assist sponsors in streamlining of development programs for new antibacterial therapies. Candidates would include products likely to have • a new mechanism of antibacterial action against bacteria that have mechanisms of resistance to other available antibacterial drugs • an added inhibitor that neutralizes a mechanism of resistance • an alteration in the structure of the molecule that makes the drug no longer susceptible to the mechanisms of resistance, or • some other characteristic that has a potential to lead to enhanced effectiveness.
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