PMTA Deficiency Letter Readiness and Response Preparation

Part 2 of a special series focusing on CTP’s requirement of PMTA submissions

With Willie J. McKinney, Ph.D., Scientific Advisor for Labstat and EAS Independent Consultant & Moderated by Michael Bond, President of Labstat International.

You are anxiously waiting to hear from FDA about your PMTA. Ideally, since the FDA has accepted and filed your PMTA, you want to hear that you have market authorization next. Unfortunately, and more likely, FDA’s next communication will be a deficiency letter, one that requires you to provide additional information in order for FDA to determine whether it can provide market authorization for your products. Your response to FDA’s deficiency letter will determine the trajectory of your review, so developing the right strategy and tone in your response is critical.

But how, without insight into your specific deficiencies, do you prepare? You will not have a lot of time to address PMTA deficiencies so how do you anticipate the FDA’s data needs and begin to address them before receiving the deficiency letter?

Join Labstat’s Scientific Advisor, Dr. Willie J. McKinney, and Labstat President, Michael Bond for a discussion on how to prepare for and develop your response to a PMTA deficiency letter including understanding expected FDA testing requirements and turn-around times. Learn what to do now based on responses received, understand what you might hear and what FDA’s next level of testing might include.

About the Presenters

Willie McKinney, Ph.D., D.A.B.T.
Scientific Advisor for Labstat and EAS Independent Consultant

Dr. McKinney is the founder and CEO of McKinney Regulatory Science Advisors, LLC, and a Board Certified in Toxicology by the American Board of Toxicology. He works with companies to resolve the complex and dynamic scientific and regulatory challenges associated with preparing new product regulatory submissions. Dr. McKinney has also served on FDA’s Tobacco Product Scientific Advisory Committee (TPSAC) as the non-voting representative of the tobacco manufacturing industry and was on the Advisory Board of the ENDS US 2019 conferences.

Previously, Dr. McKinney served as Vice President, Global Regulatory Affairs for JUUL labs, San Francisco CA and as Vice President, Regulatory Sciences for Altria Client Services, Richmond VA. Dr. McKinney’s regulatory and scientific expertise of nicotine and cannabidiol containing products will help guide Labstat’s strategic development, internal program conceptualization and internal scientific research.

Michael Bond

President, Labstat International

Michael Bond is an accomplished healthcare research and testing professional with over 20 years of experience, having held senior positions with three Fortune 500 companies, ThermoFisher, ConMed Canada and Becton Dickinson Canada, prior to joining Labstat/Labs-Mart in the summer of 2020. Mr. Bond attended the University of Western Ontario, where he received an Honours in Biochemistry and Business.

A dynamic leader with a proven track record for developing highly engaged teams, Michael employs his People, Product, Profit maxim to move organizations to exciting new horizons. The heart of Michael’s leadership strategy is based on one important principle: when a company takes proper care of its people, the people take care of the customers and the customers take care of the business.

As a people-first leader, Michael recognizes the individuals within a company are its greatest asset. That’s why the primary focus of his strategy is to attract, develop and engage the right people that will ultimately shape an organization’s future. At Labstat his teams are empowered to continuously enhance, refine and rethink the company’s solutions and develop future-ready answers to problems the industry hasn’t even thought of yet.

Michael realizes that running a fiscally responsible organization creates greater value throughout the corporate ecosystem. A healthy and profitable business creates stronger futures for the organization’s teams, customers and markets.

Posted in On Demand Webinar, Tobacco.