ARTICLE | Regulation

CABP: Pragmatism rules

New FDA community acquired bacterial pneumonia guidance is practical, feasible

January 27, 2014 8:00 AM UTC

FDA's draft guidance on developing drugs for community acquired bacterial pneumonia marks a complete reversal of policies enacted in the early 2000s and codified in a 2009 guidance document.

According to clinicians and biopharma researchers, the new draft guidance is a triumph of clinical pragmatism over statistical purity that will make it easier to develop new drugs for CABP...