Some interesting insights on off-label use - stroll to the bottom for a summary if you are interested but haven’t got time; otherwise, look for the framework that is useful for thinking about this from a physician’s point of view, which is how the regulator would like to “adopt” when thinking of the topic:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9998554/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/
https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/prescribing-information-resources
(labeling resources page which includes a video to guide industry participants whose job it is to compile prescription information)
https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label
banter and General Discussion, page-9397
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