Special Protocol Assessments Get Special Focus In Antibiotic Guidance
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA’s final guidance on use of non-inferiority studies to support antibacterial drug approval is little changed from a 2007 draft version, but it provides further clarity for sponsors operating under a special protocol assessment.
You may also be interested in...
FDA Makes It Formal, Rescinds SPA For Amarin’s ANCHOR Study
Agency makes clear that triglyceride levels are no longer an acceptable surrogate for reducing cardiovascular risk.
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Advisory Committee Splits The Difference On CABP Trials
A fierce dispute between researchers and clinicians who think community-acquired bacterial pneumonia drugs should be evaluated by their effect on mortality, and those who favor symptom-based evaluation, is unlikely to be quelled by actions taken at the Dec. 9 meeting of FDA's Anti-Infective Drugs Advisory Committee, which gave each side some of what it wanted