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Medwatch Form 3500a Download

Medwatch Form 3500a Download

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Instructions and help about fda medwatch form

thank you for the introduction again I'm Syrah and a today's topic is on FDA's adverse event reporting system also called fairs this is my disclaimer so as the outline for today's talk is introduction to fares understanding an ICS our electronic reporting of ICS RS and fares public dashboard so let's get into introduction to fares fares is FDA's post marketing safety surveillance database for drugs and therapeutic biologics it's also FDA uses fares to monitor identify and analyze adverse event and medication errors FDA staff in both cedar and Sieber they regularly use fares to examine as part of their safety monitoring routine safety monitoring and any signal centers identified from fares data is further evaluated so what does fares contain which contains spontaneous adverse event reports that are submitted to FDA from product manufacturers or directly from consumers health care professionals or other reporters and it supports FDA

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