As of May 5, 2018, all submissions to FDA must go through the Agency’s electronic gateway. There are three parts to processing electronic submissions with FDA. They are:
- Transforming the documents into pdf format.
- Placing the individual PDFs into the electronic common technical document (eCTD) backbone.
- Submitting through the FDA’s electronic gateway.
I’ll describe what is necessary for each of the steps above in a moment. But first, I’d like to ask you to think about a concept called opportunity costs. In economics, an opportunity cost is the impact of choices not made. Here’s a classic example: Billy Rose was one of the fastest typists in the world of a hundred years ago. In fact, he had gotten his start doing just that, working as a clerk. But by the time Billy Rose was a Broadway producer, he hired others to do his typing, even though he could type faster than they could. The simple reason was that for every hour he spent typing, he saved the expense of hiring a typist, but he gave up that same hour when he could have been putting together a Broadway show, something which made him much more money for each hour he put in. That’s an opportunity cost.
So, we are all familiar with taking documents produced in Microsoft Word and making them into pdfs. The software for this is readily available and relatively inexpensive. The real work is in creating internal links and bookmarks. Bookmarks are a hyperlinked table of contents to permit easy browsing through a document. Internal links are for situations where, for example, you reference a table or figure, or section of the document which does not appear on the same page. The PDF software makes it relatively easy to make the links, but it is a time-consuming and detailed process.
It is not too hard to register an account to submit through FDA’s electronic gateway. What is required is the software to complete electronic signatures on documents, which is not too pricey. FDA spells out the process for getting an account on its website. In my experience, the process works, but it takes a while.
I saved the middle item for last. Placing the individual PDFs that make up a submission into the eCTD backbone requires specialized software. There are a number of offerings of eCTD software available, all of them expensive. If your firm needs to execute several FDA submissions each year, you can spread the cost over all of them. If your firm needs to perform only a few such submissions, the cost of eCTD software per each submission becomes very high indeed.
Alas, software costs are not the only costs that you should consider as you consider the costs of eCTD submissions. This is where opportunity costs come in. Would you rather have your senior scientists spending their time inserting hyperlinks into pdfs or designing, running, and writing up research? At Pearl Pathways, we can take care of publishing PDFs, inserting them into the eCTD backbone, and submitting through the FDA electronic gateway for you at a reasonable price, allowing you and your scientists can do what you are best at: finding drugs to help patients. That’s what we do: help you speed your products to patients. Contact us to discuss how we can help you with your electronic submissions.