Why the FDA Rejected blu: The Missing Behavioral Science Evidence

Thank you to 2FIRSTS for the opportunity to share Chief Research Officer, Dr. Jessica Zdinak's perspective on the FDA’s recent denial of blu’s PMTA application.

In this exclusive interview, she highlights why robust behavioral science data, especially Module 6 and switching evidence, remains non-negotiable for regulatory success.

Too often, the industry underestimates the rigor required to demonstrate real-world switching and behavioral impact. As this case illustrates, the absence of strong behavioral evidence can be the deciding factor between approval and rejection.

Grateful for the chance to exchange insights and continue the conversation on advancing science that truly supports harm reduction.

ARAC's VISION: We envision a world where informed, science-driven decisions inspire trust, foster innovation, facilitate product development and pre-market approvals, and advance public health.

CONNECT with ARAC: https://lnkd.in/gyKzQw7c

🔗 Read the full article HERE

🔗 Read FDA notification HERE