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 today, the
FDA's Electronic Drug Registration and Listing (eDRL) mandate, which went into effect June 1, 2009,
requires the submission of OTC products in SPL
Revision 4 format through an Electronic Submissions Gateway (ESG).
From the beginning, Reed Tech has worked closely with
the FDA and the HL7 team on the SPL process. Our industry
expertise and attention to detail have enabled us to
successfully convert and validate thousands of SPLs
for top life sciences manufacturers. We can do the same
for you.
The FDA’s Center for Drug Evaluation and Research (CDER) requires OTC drug manufacturers to submit labels in the electronic SPL format, including Labeler Code Requests, Establishment Registrations, and Product Listing/Labeling submissions.
According to the FDA, content requirements for OTC SPL include Drug Facts text and Principal Display Panel text and images. Reed Tech converts your regulatory content into validated submissions and can submit them for you through our Electronic Submissions Gateway (ESG). |
