‘FDA Is Not the Villain:’ Study Highlights Need For Post-Market Focus To Spur Antibiotics
Executive Summary
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.