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Annu Rev Med. 2011;62:1-10. doi: 10.1146/annurev-med-060309-164311.

Role of postmarketing surveillance in contemporary medicine.

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1
Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA. Janet.Woodcock@fda.hhs.gov

Abstract

Contemporary medicine is a large and complex system involving many participants, all of whom play a critical role in managing the risks intrinsic to medical product use. Despite the robust premarket review and approval process of the U.S. Food and Drug Administration (FDA), new information will inevitably be learned in the postmarketing period about the safety of medicines and how they are and should be used. For much of this information, FDA relies on public reports about possible adverse events. In turn, the public depends on FDA to communicate the most up-to-date safety information on medical products to better inform treatment decisions. Expanding the scope and strengthening the capabilities of the drug safety surveillance system are among key FDA projects designed to reduce avoidable injury and death from medication use. Although improving drug safety is our goal and obligation to the public, FDA cannot protect the public adequately without the active involvement of all participants in healthcare.

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