This masterclass will examine how regulatory, political, legal, and scientific developments have shaped FDA expectations for nicotine pouch PMTAs and what that means in practice for applicants today. The panel will break down what FDA is actually requiring sponsors to demonstrate under the APPH standard, highlighting where submissions most often fall short. We will focus on how to design for authorization from the outset, integrating product chemistry, toxicology and consumer research into early development decisions as well as integrating legal arguments and defenses reduces risk. The session will also address common and costly PMTA failure points and provide practical strategies to de-risk programs before significant investment is made. Finally, we will discuss how to structure and sequence studies in a way that optimizes time, budget, and overall probability of success.

Speakers:
Chris Allen, CEO, Broughton Group
Sarah Marking, Co-Founder and Chief Strategy Officer, Sanova
Beth Oliva, Partner, Fox Rothschild
Sam Hampsher-Monk, VP Global Regulatory Strategy and Business Operations, Applied Research and Analysis Company (ARAC)

Please note there is a cost to attend.