Broughton Nicotine Services Dr Nveed Chaudhary, Chief Regulatory Officer, discusses Deficiency Letters and data gap fulfillment and why the time to act is now.
Nveed explains deficiency letter requirements and how your response can ensure your deemed product remains on the market.
Whilst in a recent post by FDA CTP, FDA highlighted that the vast number of PMTA applications means that the September 2021 date for all applications to be reviewed is unlikely to be met, the post also made it clear that PMTA deficiency letters have and are now being issued. So, if you have not received yours yet, now is the time when applicants can expect to receive PMTA deficiency letters.
If your application has been accepted for filing, congratulations, your application was deemed to have had the sufficient sections addressed; if your application has been accepted for substantive review, then congratulations again, the FDA assessed your application to be of a standard worthy of an in-depth scientific review. But unfortunately, this is where the hard work for both FDA and you as an applicant will really begin. Inevitably, you should be preparing yourselves to undergo an intensive period of study design, data collection, data interpretation and data narration when that deficiency letter does drop on your doormat; and if that is not enough to make you wake up in a sweat, FDA is likely to provide you with only 90-days to do all of this!
Now, perhaps you have already identified areas where you feel FDA might have some additional questions and have already embarked on a program of work to address those “gaps” that will be identified. Perhaps, you have already received your deficiency pack ready to send when the letter lands. But if you don’t find yourself in this state of preparedness or need some guidance on what studies to complete and to manage the process, Broughton Nicotine Services have the ability and knowledge to help you get there.
Time is of the essence
For all those applications that went in before the September 9th, 2020 deadline, we understand that for your deemed products, any delay in responding to the FDA deficiency letter means a reduction in the time you can keep your product on the market without the final marketing order. Time is of the essence, and at Broughton, we will share that sense of urgency and dedication to robust APPH evidence with you. Whether it is reassessing clinical data, additional toxicological evaluation of your ingredients, understanding the impact of your product on a cohort of society that you had not previously considered or any other aspect of the application, we will design a bespoke solution to provide you with the ability to address the deficiency letter with confidence and with control.
You can read FDA Tobacco Product Applications: Metrics & Reporting here
If you would like further information on how Broughton Nicotine Services can help with your PMTA deficiency letter, click the ‘learn more’ button below and contact us today, and together we can work to ensure that your deemed products can stay on the market for the longest period of time and over time receive a marketing order.
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