FDA M1 Promotional Material and Forms: You like it now, you’ll learn to love it later

Written by Joel Finkle, Senior Strategist, Regulatory Services Delivery

The subtitle to this week’s post comes from Robbie Roberston’s self-titled solo album, the song, “Somewhere Down the Crazy River”:

Wait, did you hear that /Oh this is sure stirring up some ghosts for me
She said "There's one thing you've got to learn / Is not to be afraid of it."
I said "No, I like it, I like it, it's good."
She said "You like it now / But you'll learn to love it later."

I’d like to think that’s how you’ll feel about FDA’s Module 1 features for forms and promotional materials, because it sets the stage for the RPS-based eCTD 4: fewer distinct document elements, more control using keywords based on controlled vocabularies.

If you take a look at the design for eCTD 3.x and the Module 1 DTDs used by various countries, they’re loaded down with a huge number of elements containing the <leaf> element. The 2006 version of FDA’s Module 1 specification has over ninety elements containing the <leaf> element (which means they can specify documents), six of those just for forms. If another form comes along, that would require another element, meaning either new versions of software, or at least some engineering to deliver a new configuration to output to the new DTD.

For version 2.0 of the Module 1, there’s just the <form> element, which has an attribute called “form-type”. The form-type attribute will contain a coded value supplied by FDA in a separate file. It currently contains 9 different forms: 1571, 356h, 3397, 2252, 2253, 2567, 3674, 3792 and 3794. The last three, by the way, are the ones not in the 2006 version, and are for the Certificate of Compliance, Biosimilar User Fee, and Generic Drug User Fee, respectively. The codes (which have names of “fdaft1” through “fdaft9” and descriptions (which are the form numbers and descriptions) are delivered in a separate XML file, “form-type.xml”. This means that this file can be replaced at the drop of a hat, and should have little or no impact on eCTD assembly or review tools.

In the 2006 version, there was only one element for promotional materials, <m1-15-promotional-material>— there was no detail for individual items, since there was no guidance for submitting promotional material. So in version 2, we have a few more elements, to differentiate between the “clean”, annotated, annotated labeling and references types of documents, but from there, everything else is controlled lists: At level 1.15, the sponsor would identify the audience type (a controlled vocabulary identifying either consumer or health care professionals), at level 1.15.1 the material document type is specified (six items: Promotional 2253 or 503b, Requests or Presubmissions for Launch or Non-Launch), and the material type is the big one, with 38 values (“Print Ad” to “TV”, “Catalog”, and “www-mobile” for instance). If all these wer emade into individual elements, you’d have (38*6*2*4 – don’t forget the four elements above) 1728 elements added.

Keywords for specifying types of things really aren’t anything new: study tagging files use them, and you can consider the drug, substance, manufacturer and indication metadata in the eCTD as the same thing. What we have for the first time, though, is identifying those keywords in controlled vocabularies that can be updated separately.

That’s the first hint of the benefits of eCTD 4: In eCTD 4, every submission type to worldwide agencies, even for different product types such as devices or food additives, would share a common XML schema (schemas replace DTDs in modern XML), and the specifics for a given submission type are just a controlled vocabulary supplied by the agencies or organizations such as ICH or IMDRF.

So do you like it?

Coming soon: report from the DIA 13th European Electronic Document Management Conference, where I will be speaking on “RPS to eCTD 4: Getting the World on Board.”