We were recently asked by the editors of Regulatory Rapporteur - the journal published by The Organisation for Professionals in Regulatory Affairs (TOPRA) - to tackle the subject of how FDA’s draft guidance on the Pre-Submission process dovetails with the drug / companion diagnostic co-development process. Our first thought was gee, isn’t there an easier topic to take on? Mideast peace, gun control, balancing the US government budget?
Okay, maybe we were over-exaggerating, but there is no denying that the Pre-Submission process is a bit complex. Sure, we get the PMA Pre-Sub, and the IDE Pre-Sub, but when do you use the IVD Pre-Sub? If you are submitting an IVD device, doesn’t that cover, well, everything?
Our reservations aside, we decided to tackle the article. The result can be found here. In the end, the decision to write the piece was a good one, because it forced us to really think about how to integrate the FDA Pre-Submission process with the CoDx development process. We found ourselves having to address the same questions that many of our pharma clients struggle with:
When should I go to the FDA with the potential CoDx device?
Should we have a IDE Pre-Submission, even if we plan to put everything in the IND?
Do we need to communicate with the FDA about the contents of the PMA?
From our exercise in writing the article for TOPRA, it turns out there are answers for these questions (early, yes and yes), and a lot of other ones as well. So take a look at our article and see what you think. Hopefully it answers more questions than it creates.