Inching toward feasibility

Clinical work on compounds to treat community-acquired bacterial pneumonia and hospital-acquired or ventilator-associated bacterial pneumonia has been in limbo since 2008 when FDA began reassessing its requirements for clinical trial designs, which many companies said asked for impossible studies.

Discussion at two recent advisory panel meetings on endpoints and admission criteria for such studies indicate the agency and the clinical community are getting closer to agreement on CABP but are not yet on the same page on HABP/VABP...