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  1. Guidance, Compliance, & Regulatory Information

Surveillance: Post Drug-Approval Activities

A vital part of CDER's mission is to monitor the safety and effectiveness of drugs that are currently available to the American people.  To meet this goal, FDA has in place postmarketing programs that monitor marketed human medical products for unexpected adverse events. These programs alert the Agency to potential threats to the public health.  Agency experts then identify the need for preventive actions, such as changes in product labeling information and, rarely, re-evaluation of an approval decision.