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FDA's draft guidance on developing drugs for community acquired bacterial pneumonia marks a complete reversal of policies enacted in the early 2000s and codified in a 2009 guidance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According to clinicians and biopharma researchers, the new draft guidance is a triumph of clinical pragmatism over statistical purity that will make it easier to develop new drugs for CABP...