Report

February 23

90 days and counting - PMTA Deficiency Letter

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. 

Deficiency Letters

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!

Data Gaps

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.

90 days and counting! PMTA Deficiency Letter

Can we help you?

Broughton Nicotine Services have deep CRO capabilities and an experienced team of scientific and regulatory professionals to manage full service global regulatory projects. Our knowledge of global regulatory pathways offers significant insights that can be incorporated into your project plans. Our mission is to accelerate safer nicotine-delivery products to market; advancing a smoke-free future.

Book a meeting with us today to discuss your requirements.

 

About the Author

Dr Nveed Chaudhary is Chief Regulatory Officer at Broughton Nicotine Services. He has over 15 years of experience in the Next Generation Nicotine Products (NGPs) industry. His educational background includes a Double Hons Degree in Pharmacology and Physiology from University College London and a PhD in Respiratory Molecular Medicine from the University of Southampton. His goal has always been to reduce the burden that lung disease has on patients, society, and public health. Early in his career he worked for the pharmaceutical industry and at Boehringer Ingelheim was the co-inventor of a novel drug for the treatment of idiopathic pulmonary fibrosis, nintedanib esylate, which received regulatory approval in 2014/15. Since 2006, Nveed had worked at three of the largest tobacco companies in the World, focused on the assessment and subsequent regulatory filing of NGPs, including e-cigarettes, heated tobacco products and modern oral nicotine products. His experience at British American Tobacco and Philip Morris International included leading multi-disciplinary, globally based teams on both pre-clinical and clinical assessment of NGPs. Later in his career at Philip Morris International, Nveed was Director of Strategic Communications, with a focus on Tobacco Harm Reduction (THR). In this role, as well as creating narratives around THR for regulatory and key opinion leader engagement, he also had a critical role in creating the narratives for the Premarket Tobacco Product Applications (PMTA) and Modified Risk Tobacco Product (MRTP) applications for IQOS. Most recently, Nveed directed the PMTA programme at Imperial Brands ensuring the timely submission of PMTA applications to support Imperial Brand’s range of deemed products in the USA. Nveed is a true pioneer for NGPs and has worked collaboratively with FDA in the submission of both PMTAs and MRTPs as well as having heavy involvement in PMTAs for both e-vapor and heated tobacco products. As a scientist and communicator, Nveed is passionate about story-telling and using scientific data to underpin the narratives of both regulatory submissions and tobacco harm reduction.