SPL Implementation Guide
Section 2.3 Correction of IG Last sentence of the first paragraph in section 2.3 of the IG, which mentions telephone number and web address for reporting adverse reactions as part of contact party information.
Section 2.1 Note of change Section 2.1 of the IG gives different URLs for the style sheet and schema than used in the current release.
Response: The FDA web sites are being reorganized and these URLs should be used in R4 SPL instances.
Section 3.2.2 Can section 3.2.2 Labeling Text could be modified to explicitly forbid the use of the mixed content model of the <text> element.
Response: The phrase in that section “The actual content is contained within a <paragraph>,or <list>” effectively forbids the placement of content as a child of <text>. General Q Keith asked if that interpretation indicated that the FDA policy concerning the IG was “anything that is not specifically allowed is forbidden”, even if it is allowed in the SPL schema. Section 184.108.40.206 Clarification needed? Any restrictions on the content of user-defined bullets in the <item>