More on Variable Material...
Yesterday I received some suggestions from a CL6 reviewer on ways to make a submission of revised variable material move more quickly. These were quite helpful and much appreciated. While there were several, one suggests that it may make sense for companies to completely re-think how they organize their Variable Material. It will certainly take some time to do, but the feedback from the Department is that it will speed the reviews and so, ultimately, that effort should pay off with faster approvals!
Here it is: The list on the variable material should match the name of the category on the form. An "excellent technique" is to number each item and also correspondingly number those items on the variable information as well as list the page numbers.
I can understand the appeal of this method from a reviewer's perspective and I do think it is worth the effort to undertake this type of revision, but there are some additional challenges in the drafting. For example if a new variable term is added (or missed in the first draft) all the numbers on both the form and the variable material need to be revised, which creates additional opportunities for error. But I always think it is worthwhile to make our submissions as easy as possible for the Department to review. If this variable material design makes their job easier, that means our filings are going to get approved faster and that means I am going to recommend going through the effort to use this method!
