Sicker Patients In Ventilator-Associated Bacterial Pneumonia Could Make Trials Easier
Public/private working group’s “interim considerations” of how best to design clinical trials for VABP and hospital-acquired bacterial pneumonia would add symptom improvement to a mortality endpoint for the latter.
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Additional draft guidances address implementation of the Drug Supply Chain Security Act, multiple endpoints in clinical trials, and public disclosure of FDA-sponsored studies.
Antibacterial Trials Can Benefit From Futility Analysis, Genentech Tells FDA
Adaptive designs and studies at multiple infection sites are among industry suggestions to the agency as possible new approaches to developing drugs to fight bacterial infections.
Pneumonia Guidances Revisited: FDA Cmte. To Weigh Study Design Issues Again
FDA’s Anti-Infective Drugs Advisory Committee will take its third look in less than four years at standards for developing antibacterial agents to treat community-acquired bacterial pneumonia, at a meeting on Nov. 3.