FDA Unveils More Details Of Drug Center Reorganization Plan

FDA's evolving plan to significantly reorganize its Office of New Drugs includes centralizing project management functions across the agency's 19 review divisions, enhancing information technology capabilities, establishing a unified post-market safety surveillance framework, and focusing on multidisciplinary teams assigned to new drug applications, FDA Commissioner Scott Gottlieb and drug center Director Janet Woodcock announced Monday (June 4). An FDA spokesperson told Inside Health Policy the agency is still working on compiling the proposal, which requires approval from Congress, the White...