Reed Tech can help. Structured
Product Labeling (SPL), which the FDA introduced
in 2005, has been steadily evolving to include more
elements and life sciences products. As of October 15, 2008, CBER required Content of Labeling submissions in electronic SPL format.
Effective June 1, 2009,
all SPL submissions must be made in SPL Revision 4 format which includes
Labeler Code Requests, Establishment Registrations,
and Drug Listings/Labelings. Additionally, the FDA requires that submissions are sent through an Electronic Submissions Gateway (ESG). |
