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.
- The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. The data presented in the visualizations above can be accessed by clicking on the link labeled "Download Patient Safety Tools Dataset" located right below the visualizations.