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  1. FHIR Specification Feedback
  2. FHIR-45535

Home page, new links in 1.2 Project Scope

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    • Icon: Change Request Change Request
    • Resolution: Not Persuasive
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    • US Pharmaceutical Quality/Chemistry, Manufacturing and Controls (PQ-CMC) (FHIR)
    • 1.0.0-ballot
    • Biomedical Research & Regulation
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      The main FDA project page for PQ/CMC – https://www.fda.gov/industry/fda-data-standards-advisory-board/pharmaceutical-quality-chemistry-manufacturing-controls-pqcmc

      is provided in the Section 1.1 on the Home page of the IG. That link provides additional links to all other relevant PQ/CMC FDA FRNs that have been published to date – there are several of these FRNs for PQ/CMC.

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      The main FDA project page for PQ/CMC – https://www.fda.gov/industry/fda-data-standards-advisory-board/pharmaceutical-quality-chemistry-manufacturing-controls-pqcmc is provided in the Section 1.1 on the Home page of the IG. That link provides additional links to all other relevant PQ/CMC FDA FRNs that have been published to date – there are several of these FRNs for PQ/CMC.
    • Smita Hastak / Norman Gregory : 14 - 0 - 0

      Home page, 1.2 Project Scope: Consider adding a link to the FDA published and draft standards (Federal Register Notice - FRN) because these data standards are not the same as HL7 FHIR data standards and some readers may get confused.

            Unassigned Unassigned
            dianawright Diana Wright
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              Created:
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