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.