FDA INTER-CENTER LABELING COMMITTEE ON ADVERSE REACTIONS
Executive Summary
FDA INTER-CENTER LABELING COMMITTEE ON ADVERSE REACTIONS has been set up to work on making ADR labeling more user-friendly. The inter-center labeling committee was formed by FDA in response to reports from physicians of inconsistencies encountered in the adverse events section of drug labeling. The committee has representatives from the Center for Drug Evaluation & Research, the Center for Biologics Evaluation & Research and the Center for Devices & Radiological Health.