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Capture of consumer details

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  • manohar hardikar
    08/08/2015 21:16
    Hello, Why is it that when a reporter is a consumer (US case), the details of the consumer are captured (in general tab in Argus database) and when a consumer is a reporter (non US case), the details are not captured. Are there any rules/ guidelines set forth by US FDA that makes pharmaceutical companies to capture consumer details? Thanks.
  • GPvP Committee
    02/11/2015 16:53
    The FDA MedWatch Consumer Voluntary reporting form (Form FDA 3500B) has a section where the US Consumer will confirm to the FDA whether they allow the FDA to share the contact information with the Company that makes the product (manufacturer) to help them evaluate the product. Outside of the US the Privacy Laws in the respective countries may preclude the collection of patient details in to the Argus database.
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