FDA Releases Strategy for Improving How the Agency Communicates Risk Information on the Products It Regulates

The U.S. Food and Drug Administration is frequently required to communicate risk information about drugs, medical devices, and biological products to healthcare professionals who prescribe and administer medical products, their patients, and consumers who buy nonprescription products. Indeed, communication about the appropriate use of FDA-regulated products is a key component in the effective management of medical product risks. It is important that these communications be clear and easily understood, yet meeting this standard is a challenging task. On September 30, 2009, FDA issued a Strategic Plan for Risk Communication, which outlines the agency’s efforts to disseminate more meaningful public health information. The plan lays out a framework for the FDA to provide information about FDA-regulated products to health care professionals, patients and consumers in the form they need it and when they need it and also explains how the agency will oversees industry communications.

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