USA – FDA finalizes bacterial pneumonia drug development guidances

The US Food and Drug Administration (FDA) on Wednesday finalized two guidances on developing drugs to treat community-acquired or hospital-acquired and ventilator-associated bacterial pneumonia.

Both guidances offer recommendations to sponsors on the development of drugs to treat bacterial pneumonia acquired in different settings and feature input on nonclinical development, trial population, efficacy trial considerations and other issues including pharmacokinetic/pharmacodynamic and labeling considerations…