STU Publication of HL7 FHIR® Implementation Guide: Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC) Submissions to FDA, Edition 2 – US Realm
Learn more at https://www.hl7.org/implement/standards/product_brief.cfm?product_id=661 or see the specification at http://hl7.org/fhir/us/pq-cmc-fda/STU2