Human studies play an important role in assessing whether the marketing of an Electronic Nicotine Delivery Systems (ENDS) product is Appropriate for the Protection of Public Health (APPH), a key contributor in a Premarket Tobacco Application (PMTA) submission to the US Food and Drug Administration (FDA).
Human studies are a pivotal component in the submission of a PMTA to the US Food and Drug Administration. Broughton Nicotine Services provide an end-to-end support service with leading industry specialists and a network of experienced Contract Research Organisation's (CRO) to ensure your data are acceptable to FDA and can inform an APPH assessment, in these key areas:
Several different types of human studies are required to demonstrate to FDA that marketing of an ENDS product is Appropriate for the Protection of Public Health. The overall aim of these studies is to demonstrate that an ENDS product poses no safety or health risks to users, and that a particular product's appeal is towards its target user and not towards unintended users.
Broughton Nicotine Services provide a turn-key service in the design, conduct and reporting of human studies in four core areas:
Broughton Nicotine services integrates all the information gathered by these studies to generate a narrative in a PMTA submission, which demonstrates whether the marketing of an ENDS product is Appropriate for the Protection of Public Health.
Broughton Nicotine Services offer a wide range of services, combined with a network of internal experts and partners, exclusively dedicated to supporting companies operating in the ENDS sector. This full-service, when integrated with our other ENDS-focused analytical and scientific services provided, supports regulatory submissions and enables new product development to advance a smoke free future.
Overview of our full-service PMTA compliance solution, from planning through to compilation and submission.
Understand what’s involved in a PMTA and how the recommendations relate to your ENDS business.