Yesterday, Dr. Jessica Zdinak took the stage at the Keller and Heckman LLP Law Symposium for a panel that cut right to the heart of what's at stake in PMTA regulation: what companies can do to prevent a denial, and how to navigate the road when one comes anyway.

Alongside attorney Eric P. Gotting, Azim Chowdhury, and Roxana Weil, PhD, DABT, Jess brought the Glas G2 case into sharp focus by walking through the science, the timeline, and what it actually takes to meet FDA's evidentiary standard for flavored products.

A few of the most important takeaways from the session:
-The administrative record is the case. By the time litigation begins, the record is closed. Every scientific decision made during the PMTA process, and every explanation provided along the way, is what the court will evaluate.
- On Glas: ARAC designed and executed a rigorous randomized controlled trial demonstrating meaningful switching and >50% CPD reduction rates that when combined accounted for a benefit to over 80% of adult smoker participants in the study. The science can't be denied. We are now waiting on the final decisions following OS scientists and leadership sign-offs on authorizations.

Grateful to Keller and Heckman for convening such an important and timely conversation.