SPL format now needed for BLA submissions

Biologics manufacturers in the USA must now submit draft labeling in structured product labeling (SPL) format to the Food and Drug Administration's Center for Biologics Evaluation and Research as part of a Biologic License Application, supplemental BLA or prior approval supplement.

The SPL mandate, which requires an XML-based, Health Level 7 standard, is the result of the FDA's e-labeling rule issued December 11, 2003, and the subsequent April 2005 guidance, "Providing Regulatory Submissions in Electronic Format - Content of Labeling." Analogous requirements have applied to drugs since October 2005.