Discovering and communicating new risks associated with approved drugs is a core part of CDER’s work. When a new drug is first approved, we know about many of the risks associated with its use from the clinical trials that we evaluated to support the drug’s approval. But once that newly approved drug goes on the market and is used by a far greater number of people than were involved in clinical trials, new safety issues—or signals—can emerge. One way we learn about many of them is by analyzing adverse event reports throughout a drug’s lifecycle (e.g., development, approval and post-approval stages).
Gerald Dal Pan, M.D., M.H.S., who is the director of CDER’s Office of Surveillance and Epidemiology (OSE), describes how the agency tracks, analyzes and acts on the adverse event data collected over time. | 
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