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MedWatch

出典:『Wikipedia』 (2011/06/06 13:27 UTC 版)

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MedWatch is the Food and Drug Administration’s reporting system for adverse events, founded in 1993. An adverse event is any undesirable experience associated with the use of a medical product. The MedWatch system collects reports of adverse reactions and quality problems, primarily with drugs and medical devices, but also for other FDA-regulated products (e.g., dietary supplements, cosmetics, medical foods, and infant formulas). Voluntary reporting by healthcare professionals, consumers, and patients is conducted on a single, one-page reporting form (Form FDA 3500). Reporting can be conducted online, by phone 1-800-FDA-1088, or by submitting the MedWatch 3500 form by mail or fax 1-800-FDA-0178.

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