Uploaded image for project: 'FHIR Specification Feedback'
  1. FHIR Specification Feedback
  2. FHIR-45468

Explain distinct Drug Products

XMLWordPrintableJSON

    • Icon: Change Request Change Request
    • Resolution: Persuasive
    • Icon: Highest Highest
    • US Pharmaceutical Quality/Chemistry, Manufacturing and Controls (PQ-CMC) (FHIR)
    • 1.0.0-ballot
    • Biomedical Research & Regulation
    • Description and Composition of the Drug Product (3.2.P.1)
    • Hide

      Add additional text to the eCTD32P10 Profile to clarify and explain how the strength and dose form define a distinct drug product – based on NDC

      Show
      Add additional text to the eCTD32P10 Profile to clarify and explain how the strength and dose form define a distinct drug product – based on NDC
    • Smita Hastak / Norman Gregory : 14 - 0 - 0
    • Clarification
    • Non-substantive

      Explain how the strength and a dose form define a distinct Drug Product. Leverage definition from NDC that explains to dose form and strength
      https://www.fda.gov/drugs/development-approval-process-drugs/national-drug-code-database-background-information

            chn@module3solutions.com CatherineHosage Norman
            chn@module3solutions.com CatherineHosage Norman
            Watchers:
            1 Start watching this issue

              Created:
              Updated:
              Resolved: