FDA-TRACK Update: CDER Launches Redesigned FDA-TRACK Webpage

Today, the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) launches a newly redesigned CDER FDA-TRACK webpage that focuses on how CDER influences and impacts drug products across their lifecycle. The new webpage utilizes a business intelligence and analytics platform that will allow external stakeholders to easily access, navigate, analyze, and download key pieces of CDER’s performance data in an entirely new way. The new technology offers interactive dashboards with informative descriptions that should provide stakeholders with more information in a single location than ever before. The webpage is organized into three main categories with seven dashboards. These three main categories are:

Policy and Science Development   Pre-Approval Safety Review   Post-Approval Safety Monitoring

The dashboards are comprised of several displays, which cover related measures. Stakeholders can navigate across several displays and interact with each to filter, drill-down, and further explore the data. Additional useful text is available as stakeholders hover over the displays. The seven dashboards include measures related to: Policy and Science Development Drugs and Biologics (Pre-Approval) Biosimilars (Pre-Approval) Generics (Pre-Approval) Drug Shortages (Post-Approval) Compliance (Post-Approval) Patient Safety Tools (Post-Approval)       CDER’s new webpage highlights a wide range of CDER-specific measures. Some are well-known, for instance, the number of New Drug Applications (NDAs), Biologics License Applications (BLAs), or First Generics approved. However, there are many other measures of CDER’s work that may be less well-known. For instance, the Policy and Science Development Dashboard shows that each month, on average, CDER’s physicians, statisticians, researchers, and many other subject matter experts typically deliver more than 100 scientific presentations at meetings and conferences both nationally and globally.  Additionally, each month, CDER's scientists publish dozens of journal articles, editorials, regulatory publications, and other types of publications that help advance the science of innovative drug safety and development.  For more information about FDA-TRACK and what other Centers across FDA are tracking, please visit our FDA-TRACK Homepage. For more information about CDER please visit CDER’s Homepage.