Issue Date: October 28, 2009
Issued by: Center for Biologics Evaluation and Research
Topic(s): Electronic Submissions,
Status: Draft
SPL Standard for Content of Labeling Technical Qs & As
This guidance is intended to assist applicants who submit content of labeling to FDA as part of a marketing application using the structured product labeling standard (SPL) in extensible markup language (XML). The guidance also provides information to FDA staff who review and manage product information using electronic systems. This is revision 1 of a guidance of the same name that was issued in December 2005. The guidance has been revised to reflect changes in the technology since 2005 and to harmonize the submission of SPL in the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). We anticipate that additional guidance will be provided as new questions arise about the use of SPL in different contexts.
Download the Guidance Document
