The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
SPL Standard for Content of Labeling Technical Qs & A
This guidance is intended to assist sponsors who submit the content of their product labeling to
the Center for Drug Evaluation and Research (CDER) using the structured product labeling
standard (SPL) in extensible markup language (XML).