The Food and Drug Administration (FDA) has announced a reorganization of its Center for Drug Evaluation and Research (CDER), specifically within the Office of Surveillance and Epidemiology (OSE) and the Office of New Drugs (OND). This reorganization aims to enhance their ability to support the FDA's mission by improving drug safety and management, addressing drug development for rare diseases, opioids, and other critical areas. The changes include creating several new offices and divisions to streamline operations and respond to legislative requirements. This structure was approved by the Secretary of Health and Human Services and is detailed in the FDA's Staff Manual Guide available online.
Simple Explanation
The FDA is changing how they organize their teams that help make sure medicines are safe and good for people, especially focusing on special and serious medicines. They're setting up new groups to make their work faster and follow new rules, but it's not clear how this affects money or how these new teams will work exactly.