Roundtable 1: Navigating the Final SIUU Guidance: Real-World Challenges and Cross-Functional Solutions 

Session details:

Navigating the Final SIUU Guidance: Real-World Challenges and Cross-Functional Solutions 

With the FDA’s finalized Scientific Information on Unapproved Uses (SIUU) guidance released in January 2025, Medical Affairs teams are reevaluating how they communicate scientific information compliantly and clearly. This interactive round table will share practical strategies for interpreting and operationalizing the new guidance—especially in the gray areas where roles intersect. Attendees will explore how to uphold transparency, scientific integrity, and regulatory compliance while supporting innovation and timely information exchange. 

• Identify key operational and compliance challenges organizations face when implementing the final SIUU guidance across teams.
• Discuss how to practically separate promotional and SIUU content during in-person and digital engagements.
• Hear how peers are updating SOPs, training materials, and internal workflows to align with the new FDA expectations. 

Ralph Rewers, Former Executive Director, Medical Sciences, US Medical Affairs, Gilead Sciences