Whilst there are still uncertainties around some of the ongoing challenges to the FDA’s Deeming Regulations, many of our clients have realised that they cannot wait any longer and have decided to initiate their PMTA process regardless.
Most are aware of the detail and depth of the process, and of the 362 Refuse to Accept (RTA) letters which were issued by the FDA after the initial flurry of applications following the August 2016 deadline.
The feedback we have had to date suggests that whilst companies are hoping for a change in the grandfather date, filing date etc., none of these changes are certainties and factors like research and testing need to be planned and started now.
We recognise there will always be the potential to reduce or cancel activities should a change occur, but many companies are starting to appreciate that the deadline is not that far away in relation to elements that take significant timelines to produce results. These include Product Characterisation/testing, Clinical & non-Clinical research, Consumer Studies, Abuse Liability etc.
As you can see from the image, there are substantial blocks of inter-dependant activities required to complete the PMTA (and minimise the risk of an RTA).
Our experience from the European Tobacco Products Directive notification process last year was that many companies left things until it was almost too late. Thankfully, we were able to add additional resource to test and submit data on that occasion. We already know that this will not be the same for the FDA process and any company missing the deadline, or being issued an RTA, will need to withdraw their products.
With some clients already 9-10 months along the process capacity for certain elements is becoming increasingly limited, and the potential to deliver in time for the deadline will soon be challenging. We are working with a number of clients on their PMTA process and have placed Project Management resource directly within some US-based clients to support this.
Given the current scenario a number of clients are asking about what a “starter package” might look like, covering the essentials to kick off the process in the next few weeks. Please contact us for further information on how Nerudia can support you.
Senior Consultancy and Compliance Officer