This occasional column provides summaries of newly released FDA guidances of interest to our readers.
Two final guidances the FDA released last week provide an outline for trials of drugs to treat hospital- or community-acquired or ventilator-associated bacterial pneumonia. The guidances point out considerations for trial design, trial population, entry criteria, sampling, dose selection, efficacy endpoints and statistical analysis.
To read the hospital-acquired and ventilator-associated guidances, click here: https://bit.ly/2Ack66s.
To read the community-acquired guidance, click here: https://bit.ly/3g3IoPi.