ML26026A158
| ML26026A158 | |
| Person / Time | |
|---|---|
| Issue date: | 01/22/2026 |
| From: | Katherine Tapp Office of Nuclear Material Safety and Safeguards |
| To: | |
| References | |
| Download: ML26026A158 (2) | |
Text
Drop-In Notice and Summary January 22, 2026
SUBJECT:
VIRTUAL DROP-IN VISIT WITH NOVARTIS ON January 22, 2026 TIME:
10:30 AM - 11:00 AM MEETING ATTENDEES:
U.S Nuclear Regulatory Commission Novartis Andrea Kock, Director, NMSS Amy Roma, Associate, Hogan Lovells Dafna Silberfeld, Acting Division Director, Division of Materials Safety, Security, State, and Tribal Programs NMSS Leah Ralph, Federal Policy Lead, Novartis Kathryn Brock, Deputy Director, NMSS Stephanie Fishman, Senior Associate, Hogan Lovells Chris Einberg, Branch Chief, Medical Safety and Event Assessment Branch (MSEB)
Tom Boike, MD, Novartis Katie Tapp, MSEB Mark Fallick, MD Novartis Sarah Spence, MSEB Taylor Booth, Novartis TOPIC(S):
Introduction to Novartiss Radioligand Therapy Authorized User Supervision of Radioligand Therapy
SUMMARY
Novartis met with NRC staff to discuss regulatory issues related to their Radioligand Therapy (RLT) products. Novartis provided an overview of RLT and explained their current distribution process for delivering patient-ready doses to medical use sites. They shared statistics on patient populations, production capacity, and distribution timelines, and highlighted the growing demand and anticipated expansion of RLT in the future.
Novartis noted that ambiguity in NRC guidance regarding Authorized User (AU) supervision requirements has created challenges, resulting in inconsistent regulations among Agreement States. Some states impose stricter requirements than the NRC, such as mandating that an AU be physically present during administration or within one hour of the administration site. Novartis emphasized that these requirements are burdensome given the limited number of AUs nationwide. They requested that NRC issue guidance or consider rulemaking to clarify that physical presence is not required. Novartis plans to submit written comments for NRC consideration. NRC staff advised submitting comments promptly due to the EO 14300 timeline for rule publication and stated they would review Novartiss input and consider issuing guidance or incorporating it into ongoing rulemaking.
- This meeting was a general exchange of information not directly related to any regulatory action or decision.
Name of Summary Author: Katie Tapp Date of Final Summary Issuance: January 22, 2026