88436-1

LOINC 2.82

FDA package insert Patient counseling information

FDA insert Patient counseling inform

Definition

  • Patient counseling information for human prescription drugs and biological products as described in the Physician Labeling Rule and associated guidance document.[https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368602.pdf]

Component

  • Patient counseling information

Specimen / system

  • ^FDA package insert

Class

  • DOC.REF

Property

  • -

Scale

  • Nar

Related names

  • DOCUMENT.REF; FDA insert; Narrative; Report; SPL; Structured Product Labelling

Index terms

  • DOCUMENT.REF
  • FDA insert
  • Narrative
  • Report
  • SPL
  • Structured Product Labelling