Five Potential Problems to Avoid when Creating a Structured Product Label (SPL)
In the scheme of a large submission such as an original New Drug Application (NDA), the accompanying Structured Product Label (SPL) is often an afterthought. Small in scope should not be confused for simple – the SPL ranks as the most complex piece of your submission.
The SPL standard is based on extensible markup language (XML), and the intricacies of this format are difficult to grasp. If you are unfamiliar with XML the probability of submitting an SPL containing errors increases, and reported errors are difficult to correct.
A number of common errors have surfaced again and again as we work with sponsors to create, validate and submit SPLs. Here are five mistakes you want to avoid:
Determining Data Needed for SPL Submission
As was mentioned in our introduction, an SPL is a small part of your complete eCTD submission, but it’s very dense and contains a significant amount of data. Many of our sponsors have difficulty interpreting what information they are expected to provide based on existing Agency guidance documents. There are a lot of fields to complete in an SPL and the slightest error can result in a rejection. GlobalSubmit’s eCTD publishing team has compiled a master list of deliverables and data as it relates to SPL creation, and this list is available to our clients.
Once errors in the SPL are identified, those errors must be understood. We say understood because there are certain errors that are expected for draft SPLs. Although XML tools, such as the one made available by the US FDA, will inform you of the errors, they will not be able to tell you whether those errors are expected or should be resolved. This is where GlobalSubmit publishers can provide reassurance. In the case of final labels, a failure to correctly resolve errors forces you to file a resubmission with little to no confidence of avoiding further work. The back and forth dialogue created between sponsor and Agency can drag on for days, and prolong the overall submission process.
The contents of a Structured Product Label (SPL) are often delivered as a Microsoft Word document partitioned into sections. There are instances when sections are pasted into the SPL creation tool in the proper order, yet when the submission is validated, those sections are reordered. For example, Section 2 suddenly appears as a floating section. Yet to the user, there is no indication of a problem prior to validation. Again, fixing this error requires direct manipulation within the XML. The built-in tool available is not suitable for resolving the issue.
Creating and formatting tables is done directly in the XML. The FDA’s built-in tool for SPL creation offers very limited granularity for this particular task. If your SPL requires a greater degree of granularity than setting the number of columns and rows, manual edits to the SPL are needed.
Inserting and modifying hyperlinks is another action that’s possible yet unpredictable using the built-in tool available to sponsors. Errors frequently occur in the XML and unless you are extremely knowledgeable of this process, you are exposed to greater risk.