FDA Roundup: March 26, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA proposed a ban of electrical stimulation devices intended to reduce or stop self-injurious or aggressive behavior, a step rarely taken by the agency. The agency has determined that these devices present an unreasonable and substantial risk of illness or injury. This is the second time the FDA has proposed a ban of these particular devices. On Monday, the FDA announced the Center for Drug Evaluation and Research’s new Quantitative Medicine (QM) Center of Excellence (CoE).Quantitative Medicine (QM) Center of Excellence (CoE). The goal of this CoE is to facilitate ...