‘FDA Is Not the Villain:’ Study Highlights Need For Post-Market Focus To Spur Antibiotics
A study of drug approvals over more than three decades shows antimicrobials, including antibacterials, had consistently shorter development and review times than other types of products. While antibacterials were less likely to participate in special US FDA programs designed to help along review, experts said reimbursement reform, not new regulatory flexibility, is needed to help address the crisis of drug-resistant infections.
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As HHS develops strategic framework to combat antibiotic resistance, post-market financial incentives may not be included, despite prominent government panels recommending the idea years ago and GAO urging the department to do so in a just-released report. Stakeholders told that GAO reimbursement reform won't be enough to spur a strong antibiotic pipeline.
The negative attention from Capitol Hill over the approval of the antibiotic Ketek is impacting much more than the commercial prospects of a single drug: it's making FDA reviewers think twice about other applications.
FDA Panel Will Have To Weigh Pediatric Cancer Drug’s ‘Higher Level’ Of Uncertainty Against Rare, Devastating Disease
US WorldMeds NDA package for eflornithine for high-risk neuroblastoma provides “a higher level of uncertainty than is typically seen in oncology applications,” agency says. Though FDA seems largely satisfied with the sponsor’s externally controlled study, confirmatory evidence may be lacking.