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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Center for Drug Evaluation & Research - Post-Approval Safety Monitoring

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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.


Drug Shortages - CDER Dashboard

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.


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