FDA regulated industries, including the ENDS industry, have few opportunities to engage with the FDA and receive valuable, bespoke product and issue-specific feedback directly from the Agency. An example of such opportunity is a private meeting with the FDA Center for Tobacco Office of Science. In addition to providing better direction for the applicant’s research plans, FDA meetings are crucial for the respective industry participant’s resource allocation. Important resource commitments, such as research and the submission of a PMTA, can only be successful through a continuous dialogue with the FDA, which generally may only take place in the context of a private industry meeting.
Furthermore, FDA itself encourages all applicants to meet with the FDA before initiating any type of research to ensure that the applicant has a clear understanding of FDA expectations. To assist the industry with FDA meetings, Broughton developed a guide to requesting a meeting with the FDA and we are pleased to introduce it here.