645 - Hello PAAB! Can sales representatives distribute a tool that was approved by PAAB as DTC to physicians to provide to potential patients? Would this tool need to be re-submitted through PAAB as unbranded patient material? Thank you!

[Jennifer Carroll]

Yes. To avoid this in the future, you can inform us that the piece will be viewed by both audience types during our initial review. The rationale is that materials viewed by the different regulatory audiences (i.e. consumers vs patients vs HCPs are subject to different regulations.