The “Who” in SIUU
- May 14
- 1 min read
Off-label discussions have traditionally been managed by Medical Affairs, but that may be shifting. FDA’s January 2025 guidance on Scientific Information on Unapproved Uses of Approved/Cleared Medical Products (SIUU) does not specify which function can discuss data on non-approved uses.
What the guidance states is that personnel who communicate SIUU should be specifically trained to provide truthful, non-misleading scientific information about unapproved uses of the company’s approved products, but it does not limit this to medical. The focus is on scientific exchange, not commercial messaging.
At your company, who is permitted to engage in SIUU discussions?
Medical
Commercial
Undecided
Both
