FDA Antimicrobial Drug Guide Lacks Added Detail Sought By Industry

An industry expert expressed frustration with the lack of detail in FDA’s final guidance that lays out a pathway to expedite antimicrobial drugs that treat serious or life-threatening diseases in limited patient populations. The expert says FDA failed to lay out a more detailed line of thinking from what was in the draft guide, and it seems FDA did the bare minimum to meet the statutory requirements for the program as laid out in the 21st Century Cures Act. FDA’s...