Hospital-Acquired Pneumonia Is Life Or Death, FDA Says; Recommends All-Cause Mortality As Sole Primary Endpoint
This article was originally published in Pharmaceutical Approvals Monthly
Rigorous enrollment criteria and strict endpoints characterize FDA's new draft guidance on developing drugs for hospital-acquired and ventilator-associated bacterial pneumonia, even compared with the agency's recent draft guidance on developing drugs for community-acquired bacterial pneumonia.
You may also be interested in...
FDA's final guidance on non-inferiority studies in antibiotic drug development is little changed from the 2007 draft version, but provides further clarity for sponsors working under an SPA.
FDA's pending guidance on clinical trials for antibiotics to treat hospital- and ventilator-acquired pneumonia can't help but add a measure of stability to the uncertain regulatory environment in the field, but stakeholders fear that when the clouds part, the view will be of a very high bar.
Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.