Dear Colleagues,

I am a few years departed from being in this space and hoping to get a refresher; My company is looking to transition one of our last US patient from a clinical study to a Single Patient IND, and the program is not yet commercial. Our current dilemma is that we still have ample level of clinically labeled supply from the original clinical study, and would like to leverage this supply to continue supporting the last patient who is rolling over versus developing new supply.

What are some of the requirements or best practices with going about this?

We are thinking, at minimum, applying an auxiliary “For Compassionate Use Only” label to apply onto the existing clinical study label. But would it also be a best practice to also apply a strikethrough label to strike the original study identifier(s)?

Thanks in advance!