Articles tagged with “structured-product-labeling”

Structured Product Labeling (SPL): Automation & AI Trends

Explore FDA Structured Product Labeling (SPL) standards, current automation challenges, and how AI integration optimizes pharmaceutical regulatory workflows.

40 min read

2/23/2026

structured product labeling spl automation fda compliance pharmaceutical labeling regulatory affairs ai in pharma xml data standards hl7 standards generative ai electronic labeling

Structured Product Labeling (SPL): A Guide to Data Integrity

Updated 2026 guide to Structured Product Labeling (SPL) and data integrity. Covers FDA mandates, EMA ePI roadmap, Health Canada XML-PM, FHIR standards, and ALCOA+ compliance for pharmaceutical labeling.

35 min read

11/23/2025

structured product labeling spl data integrity pharmaceutical labeling regulatory affairs fda regulations hl7 alcoa+