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

Venue: Sheraton Philadelphia City Center

Location: Philadelphia, Pennsylvania, United States

Event Date/Time: Oct 29, 2008 End Date/Time: Oct 30, 2008
Report as Spam


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.

• 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.