An FDA Final Rule issued 11 Dec 2003 and effective 8 June 2004 requires submission of the content of labeling in electronic format for NDAs, certain BLAs, ANDAs, supplements, and annual reports (even for paper applications!).

The implementation of this new labeling format has escalated the need for organizations to develop a strategy for SPL capabilities. The new standard is enabling industry to gain new efficiencies through electronic processes. It has also created a need for transition support. In order to meet this need, Octagon has developed a collection of service offerings that support the transition to SPL.

Octagon's SPL Stewardship Program offers:

• SPL Training
• SPL Conversion Services and Submission Compilation
• SPL Capability Consulting

This customizable program allows your organization to select the appropriate support that complements existing skill sets and capabilities.

HL7 Organization Member
Role on SPL Implementation Team

Leadership Role and Active participation in:

• Drug Information Association (DIA) SIAC and Programming Committees
• Regulatory Affairs Professionals Society (RAPS)

For more Information about Octagon's Submission Stewardship Program and how you can gain new efficiencies through electronic processes

>> Download PDF of SPL Stewardship Datasheet or Contact Octagon