Modernizing FDA’s Drug Review Processes for Transparency and Efficiency

The U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) is responsible for ensuring the safety and efficacy of drugs available in the United States. To enhance data transparency, streamline management, and improve reporting, CDER sought to modernize its drug review process across the drug lifecycle and harmonize business processes across various offices. To achieve this, CDER aimed to replace its legacy systems—such as DARRTS and Panorama—with a unified, scalable platform. The Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) is a platform for CDER to manage, track, and report drug applications, while Panorama automates FDA review and project management tasks. A key challenge in transitioning from these legacy systems was ensuring the new platform could handle complex workflows and meet the diverse needs of CDER offices.