Request to add Note element to Ingredient Resource

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    • Type: Change Request
    • Resolution: Unresolved
    • Priority: Medium

      We need a Note or Comment element in Ingredient Resource.  Similar to the one in SubstanceDefinition resource.  In eCTD Module 3, often times a sponsor needs to provide some additional information about a particular ingredient of the drug product and that information cannot be provided else where.  Its a text field.

      New Element: Note

      Definition: A placeholder for providing any comments that are relevant to the drug component.
      Examples: removed during process, adjusted for loss on drying, etc.

      Cardinality: 0..*

            Assignee:
            Smita Hastak
            Reporter:
            Smita Hastak
            Catherine Hosage Norman, Smita Hastak
            Watchers:
            3 Start watching this issue

              Created:
              Updated: