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    • Icon: Change Request Change Request
    • Resolution: Persuasive with Modification
    • Icon: Medium Medium
    • US Pharmaceutical Quality/Chemistry, Manufacturing and Controls (PQ-CMC) (FHIR)
    • 1.0.0-ballot
    • Biomedical Research & Regulation
    • eCTD Product Description and Composition
      eCTD Specification Composition
      eCTD Substance Control of Materials Composition
      eCTD Substance General Information
    • Hide

      Based on discussion with FDA team, both the identifiers will be made optional.

      Show
      Based on discussion with FDA team, both the identifiers will be made optional.
    • Smita Hastak / Norman Gregory : 15 - 0 - 0
    • Correction
    • Non-compatible

      If you're going to require support for both Bundle.identifier and Composition.identifier, best to explain the intended use of each.

            chn@module3solutions.com CatherineHosage Norman
            lloyd Lloyd McKenzie
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              Created:
              Updated:
              Resolved: