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Highlights Text and Data Elements in Structured Product Labeling

Presentation: January 25, 2006
Randy Levin, M.D.
Director for Health and Regulatory Data Standards
Food and Drug Administration

Overview

• Sections with highlights text
  • Box Warning
  • Recent Major Changes
  • Indications and Usage
  • Dosage and Administration
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Drug Interactions
  • Use in Specific Populations

• General labeling information
  • Reporting information
  • Approval information

• Pharmacological class by ingredient and/or product
  • Mechanism of action, physiologic effect, structure class

• Interaction and adverse reaction
  • Contributing factor
  • Type of consequence
  • Consequence

• Indication
  • Indication
  • Outcome of use
  • Limitation of use
  • Maximum dose

Further Information

• Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
  • Federal Register: January 24, 2006 (Volume 71, Number 15)

• HL7 Structured Product Labeling Release 2 Specifications (PORR_MT050024)
  • www.hl7.org

• HL7 SPL working group
  • Implementation guide development

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