FDA-TRACK is FDA's agency-wide performance management program that monitors, analyzes and reports key performance data and projects for FDA's program offices and cross-cutting initiatives.
CDER incorporates patient safety in virtually all our regulatory actions and initiatives. From working to ensure safety protocols in clinical trials, to evaluating safety in our review and approval process, to overseeing quality standards in manufacturing, to keeping up with scientific and clinical research, to engaging patients, caregivers, and health care professionals in our decision making, to monitoring drug safety after approval, and much more, safety is essential to all our work. In this section, we report two particular safety activities: 1) Risk Evaluation and Mitigation Strategies (REMS), and 2) the FDA Adverse Event Reporting System (FAERS). REMS programs are specific extra safety measures that patients, manufacturers, health care professionals, and others must take prior to a patient using a drug. Each REMS is tailored to a certain drug or drug class and is designed to help ensure that the drug’s benefit outweighs its risk. FAERS is an FDA database of adverse events from medical products as reported by manufacturers, patients, health professionals, and others. These data are critical for FDA to monitor the post-market safety of FDA-approved products.
For a complete list of CDER measures and their relevant FDA-TRACK dashboard, refer to the FDA-TRACK CDER Index.