The new Granularity Annex document from FDA says that numbering of sections within documents does not have to include the documents numbering. Will ISIWriter be incorporating this change?
Excerpt: “Section Numbering Within Documents In order to avoid 5th, 6th, etc., level subheading numbering (e.g., 2.6.6.3.2.1) within the applicant can use a shortened numbering string. In this case, the document name (e.g., 2.6.6 Toxicology Written Summary) should appear in page headers then section numbering within the document can be used, for example, 1, 1.1, of the full numbering string (e.g., 2.6.6.3.2.1) is also considered acceptable.” The Granularity Annex gives you an ‘out’ so that you don’t have to ‘use up’ heading levels 1-5 just to start your document with heading 2.6.6.3.2.1. ISIWriter uses a ‘prefix’ so that you’re still using Heading 1, with “2.6.6.3.2.” attached to each number as a fixed string of characters, avoiding the problems. We have not yet decided whether to make changes to the templates based on the new guidance.
