top of page

The Logic Behind the Labeling: Answers to Your SPL and SPM Questions

  • Writer: Marianne Calilhanna
    Marianne Calilhanna
  • 50 minutes ago
  • 1 min read

Structured Product Labeling (SPL) and Structured Product Monographs (SPM) play a critical role in how the FDA receives, processes, and evaluates product information. These two acronyms carry a lot of weight in the world of regulatory compliance in the United States. Whether you're just getting started or have experience navigating these structures, DCL provides clarity on key submission requirements, common challenges, and lesser-known nuances that impact compliance and data integrity.

What is Structured Product Labeling? It's a way to help a computer make sense of drug labeling text.

Browse through key moments in the following discussion or enjoy the full recording of SPL and SPM: Ask the Experts.


bottom of page