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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Center for Drug Evaluation & Research - Pre-Approval Safety Review

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.

Any drug approved by FDA must be demonstrated to be safe and effective.  Both measures are extensively assessed during a drug’s premarket drug development process.  Testing is conducted in a variety of progressive phases that begin with laboratory testing, move to animal testing, then to small groups of human subjects, and finally to larger groups of human subjects in full clinical trials.  Since all drugs have risk, safety is assessed relative to the drug’s effectiveness.  A drug’s benefits must outweigh its risks for the agency to consider it safe and effective.

For a complete list of CDER measures and their relevant FDA-TRACK dashboard, refer to the FDA-TRACK CDER Index.

FDA-TRACK CDER Home

Drugs and Biologics Dashboard

Prior to approval, new drugs go through many steps, or “phases” during the approval process.  They are first tested on animals, then on small groups of humans for preliminary safety information (phase 1) and again on small groups of people to get a preliminary review of the drug’s effectiveness (phase 2).  Very few drugs make it past these early phases, as companies and/or CDER often find early signs that the drug may not be as safe or effective enough.  For the relatively few drugs that pass these hurdles, phase 3 clinical trials are the next step.  Generally, this phase involves a much larger group of people. Clinical trial patients take the drug over an extended period of time under the supervision of scientists and health care professionals who assess the overall risks and benefits of the drug.  Drugs that still show potential for safety and effectiveness after phase 3 trials are the ones that FDA considers for approval.  It is important to note that FDA is not responsible for conducting clinical trials. It assesses the data from clinical trials to evaluate drugs during the approval process.

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