FDA Should CAP Its Superiority Trial Requirement For Antibiotics, Journal Says
FDA should refrain from extending its moratorium on non-inferiority trials to antibiotics for the treatment of community-acquired pneumonia, an editorial in The Lancet Infectious Diseases advocates
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Industry has provided little data supporting the use of non-inferiority trials as the basis for approval for community-acquired pneumonia, FDA Office of Medical Policy Director Bob Temple said at a recent workshop on clinical trial design for CAP
FDA is clarifying that it expects sponsors to provide analysis of efficacy data rather than simply a summary of clinical data as part of the integrated summary of effectiveness in new drug applications
Interim data from SHARP and IMPROVE-IT trials fail to show evidence of impact on cancer rates.