FDA-TRACK: Center for Drug Evaluation & Research - Pre-Approval Safety Review - Drugs and Biologics Dashboard
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.
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 be not 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.
Data contained in the dashboard is not final, but accurate at the time of posting; refer to the PDUFA Performance Reports to Congress for official data.
For a complete list of CDER measures and their relevant FDA-TRACK dashboard, refer to the FDA-TRACK CDER Index.