Timelines to approve RAM licenses
The approval timeline depends on several factors, including the complexity of the application, the completeness of the submitted documentation, and whether the regulator requests additional documentation or clarification.
The NRC publicly states that after submitting an NRC Form 313 application, the initial review can take approximately 90 days — but real-world experience varies, and these timelines also vary by state. The NRC and state regulators may request additional follow-up that adds time. As a result, it is important when starting an Ac-225 facility to be prepared for the RAM license approval to be a rigorous and potentially lengthy process — often 6 months or more — and to therefore begin as early as practical.
What drives the timeline
Completeness of submission
Incomplete applications generate Requests for Additional Information (RAIs); each RAI round typically adds weeks. A pre-submission consultation with the assigned reviewer dramatically reduces RAI cycles.
Familiarity of the request to the regulator
Adding an isotope the program has never authorized (or that the regulator sees infrequently) typically gets more scrutiny than incremental quantity changes against an existing authorization.
Reviewer workload
Some Agreement State medical-use teams are very small. A direct conversation with the assigned reviewer is often the single best predictor of how long your specific package will take.
It is recommended to directly contact the NRC, the state regulatory agency, or consult their regulatory guides for facility-specific timing.