Antimicrobial Drugs Advisory Committee

On Thursday, April 13, 2017, the Antimicrobial Drugs Advisory Committee (AMDAC) discussed the development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections. Overall, the Committee supported the conduct of non-inferiority trials with expanded margins to support approval. The Committee did not support the use of data obtained from studies of animal models as a sole basis for approval.