Supplement Adverse Event Reporting
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The term serious adverse event is an adverse event that a results in i.
Supplement adverse event reporting. Thus reporting via an aers is fundamental to detecting subject safety issues and mitigate the relevant risks with planning. To facilitate the reporting of adverse events the labels of dietary supplements marketed in the united states must include a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement fdca 403 y. In october 2007 two months before the reporting requirements became effective the food and drug administration fda issued guidance questions and answers regarding adverse event reporting and recordkeeping for dietary supplements as required by the dietary supplement and nonprescription drug consumer protection act 1 specifically.
2 serious adverse event. A serious adverse event report is a report that must be submitted to fda using the medwatch form when a manufacturer packer or distributor of a dietary supplement receives any report of a. However it is estimated that less than 2 of aes are reported.
Questions answers regarding adverse event reporting and recordkeeping for dietary supplements as required by the dietary supplement nonprescription drug consumer protection act issued in october 2007 is a helpful guide for compliance with saer requirements. Therefore it is particularly important for consumers health professionals and industry members to report serious health related reactions or illnesses also known as adverse events to fda so. Adverse events reporting system is crucial for detecting processing reporting adverse drug supplement associated events.
Aes related to use of ds are not uncommon. The dietary supplement and nonprescription drug consumer protection act signed into law in december 2006 requires manufacturers to report to fda serious adverse events aers associated with dietary supplements whether or not a likely causal connection is established. Fda s guidance for industry.
Fda data of reported adverse events can be misconstrued says kingston. Serious adverse event reporting for dietary supplements a definitions.
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