The system also supports the FDA's Structured Product Labeling (SPL) standard, which requires pharmaceutical companies to submit the content of labeling in an XML-based format for NDAs and clinical trials. The XML-centralized electronic database is easy to search compared to the previous methods of PDFs or hard copy.
The purpose of SPL is to speed up the approval process, says Kerluk. "The FDA is more receptive to this electronic data format."
Kristen Giovanis, managing director of KJ International Resources, a language services company, says that implementing a content management system that integrates with SPL requirements has been an expensive and challenging endeavor for many companies; however, now is the time to make changes: SPL comes at a time when many companies are already rethinking their labeling strategies to meet FDA's new labeling format requirements for new and recently approved prescription drugs. The prescription drug labeling rule goes into effect in June. [HCP]
By Kassandra Kania
Kassandra Kania is a freelance writer based in Charlotte, NC. She has covered healthcare packaging for several years, most recently as a trade publication editor.