FDA Panel Vote on CAP Studies Could Affect Pending NDAs

IDSA does not say that mortality must be a component of a composite but that there are advantages of having it in there, that if it is a problem one could argue just for morbidity endpoints The FDA is re-evaluating the appropriateness of using noninferiority trial designs for anti-infectives used to treat community-acquired pneumonia , which could affect firms like Woodridge, Ill.-based Advanced ... via BioWorld

[Aubrey Anderson]

Strange that the FDA would be looking at changing the approval process now when so many people are dying each day from MRSA, Pneumonia and other antibiotic resistant illnesses? You would think the opposite, they would be looking for a speedy process to approve new safe antibiotics that work?