Structured Product Labeling (SPL) Preparing for FDA Electronic Drug Registration and Drug Listing

29 - 30 October 2008, Philadelphia, PA, United States

Introduction

The FDA Amendments Act placed into law the requirement for electronic drug establishment registration and drug listing. FDA is adopting the use of extensible markup language (XML) files in a standard SPL format as the standard format for the exchange of drug establishment registration and drug listing information.

KEY TOPICS
• Electronic drug establishment registration and listing SPL
• Data Universal Numbering System (D-U-N-S®)
• Electronic Submissions Gateway (ESG)
• SPL reference documents
• SPL lifecycle management
• Listing data elements/Terminology
• Transitioning from paper to electronic.