FDA-TRACK: Center for Drug Evaluation & Research - Post-Approval Safety Monitoring
Subscribe now!
Interested in receiving FDA-TRACK updates in your inbox?
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.
Even the best clinical trials cannot ensure a drug is completely safe and effective. Trials are often conducted on relatively small populations of test patients. After a drug is approved, that same drug can be taken by thousands or even millions of patients. With this large-scale use, new risks and new information about the drug’s effectiveness are often found. FDA maintains a system of postmarketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug approval process. FDA monitors adverse events such as adverse reactions and poisonings. FDA uses this information to update drug labeling, and, on rare occasions, to reevaluate the approval or marketing decision. FDA also oversees problems that may occur with the manufacturing, distribution, or availability of a drug. Monitoring the safety and effectiveness of drugs after they are approved and widely used is an important part of CDER’s work.
For a complete list of CDER measures and their relevant FDA-TRACK dashboard, refer to the FDA-TRACK CDER Index.
FDA-TRACK CDER Home
FDA takes great efforts, within its legal authority, to address and prevent drug shortages, which can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. FDA responds to potential drug shortages by taking actions to address their underlying causes and to enhance product availability. FDA determines how best to address each shortage situation based on its cause and the public health risk associated with the shortage by working with firms to address any potential risks to keep medically necessary products available while also ensuring there is not going to be harm to patients associated with the quality issues.
For additional information, click on the links below.
FDA has established a wide array of guidance and regulations to help assure patients have access to high-quality over-the-counter and prescription medications that are safe and effective. CDER diligently works to ensure compliance through facility inspections, product testing, and other pre- and postmarket actions, including enforcement actions, in the United States and globally. This work includes oversight of clinical trials, commercial manufacturing of raw and finished products, compounded drugs, supply chain integrity, drug recalls, product labels, drug registration and listing, and post-market safety requirements.
For additional information, click on the links below.
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 additional information, click on the links below.