Section 1.15 of the US NDA covers Promotional Materials. There’s a list of subcategories in 1.15.1 related to correspondence, and 126.96.36.199 is the promotional material itself. Rather than creating dozens of XML elements in the DTD for these categories, FDA has added some new metadata. There is a promotional-material-audience-type containing a code indicating “Consumer” or “Professional” for all of 1.15, and promotional-materials-doc-type and promotional-material-type for 1.15.2. The doc-type indicates the type of submission, e.g. “Promotional 2253” or “Presubmission Accelerated Launch” no more 3-letter codes on the 2253 form. The material-type indicates the type of material (website, print ad, sales-aid, etc.) and that XML element has sub-sections to indicate the Clean, Annotated, Annotated Labeling or Annotated References versions of those materials.
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