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    • Icon: Change Request Change Request
    • Resolution: Persuasive with Modification
    • Icon: Highest Highest
    • Electronic Medicinal Product Information (FHIR)
    • 1.0.0-ballot
    • Biomedical Research & Regulation
    • STU
    • Steps to create ePI Type 2
      Steps to create ePI Type 3
    • 5.1.9
    • Hide

      There is a way to convey this information using the ClinicalUseDefinition.warning.code

      We will update the narrative to better describe warning types

      Show
      There is a way to convey this information using the ClinicalUseDefinition.warning.code We will update the narrative to better describe warning types
    • Craig Anderson / Norman Gregory : 7-0-0
    • Clarification
    • Non-substantive
    • Yes

    Description

      There may be a need to characterize warning types – e.g., in the US, black box warnings are the most serious warning type and should be distinguished from other warnings.

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            celine_lefebvre Celine Lefebvre
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              Updated:
              Resolved: