CSC: “As Advertised” - FDA Module 1 Continued – By Joel Finkle, Senior Strategist, Regulatory Services Delivery

Picking up where we left off last time on the FDA Module 1 changes the other big news is that the Office of Prescription Drug Promotion (OPDP), formerly Division of Drug Marketing, Advertising and Communications – DDMAC, is finally getting with the 21st century: promotional and marketing materials can now be electronically submitted in the eCTD. Currently, much of the promotional materials can be sent electronically, but only on hard media such as CDs, not through the gateway, and not in eCTD format.

Promotional Materials

Section 1.15 of the US NDA covers Promotional Materials. There’s a list of subcategories in 1.15.1 related to correspondence, and 1.15.2.1 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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