Summary of FDA’s New Final Guidance: Scientific Information on Unapproved Uses

On January 6, 2025, FDA finalized guidance, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (Final SIUU Guidance). The Final SIUU Guidance replaces FDA’s draft guidance issued in 2023 and updates FDA’s policy and recommendations for permissible proactive off-label communications to healthcare providers.  

Join us to discuss the Final SIUU Guidance, including important changes from the 2023 draft guidance. Key topics include: 

• evolution from “reprints” to SIUU communications;
  
• SIUU source publications and firm-generated presentations;
  
• scope of the “scientifically sound” standard;
  
• SIUU presentation considerations and risks; and
  
• First Amendment implications.

For questions, contact Christine Lieber.