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Session 6: SIUU Who? Best Practices and Limitations
Session Chair(s)
Alyson Andrikanich, PHARMD
Senior Director, Advertising and Promotion, Regulatory Affairs Americas, Bayer, United States
Nicol George, PHARMD, RPH
Vice President US Regulatory Affairs, Galderma, United States
This session will examine the evolution of the FDA’s Good Reprint Practice guidances leading up to the finalized 2025 Scientific Information on Unapproved Uses (SIUU) guidance, highlighting both new elements and limitations. Attendees will learn about materials that qualify or do not qualify for dissemination under SIUU and the critical role of the regulatory reviewer in the approval and dissemination processes. An interactive component will allow participants to evaluate SIUU scenarios to reinforce their understanding of the guidance and discuss practical and compliant execution.
SIUU Who? Best Practices and Limitations of the Scientific Information on Unapproved Uses Guidance
Olivia Estridge, Jazz Pharmaceuticals
Joshua Oyster, Ropes & Gray
Learning Objective :
At the conclusion of this session, participants should be able to:
- Assess what types of materials qualify for dissemination under SIUU guidance
- Illustrate the promotional review team’s role in review, approval and execution of SIUU dissemination
- Identify regulatory expectations and practical considerations for compliant communication of scientific information on unapproved uses
Speaker(s)
SIUU Who? Best Practices and Limitations of the Scientific Information on Unapproved Uses Guidance
Director, Jazz Pharmaceuticals, United States
Speaker
Partner, Ropes & Gray, United States
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