748 - Hello what kind of references are required to make a claim about number of patients treated with drug/device X worldwide? and about availability in x number of countries? Does Data on file suffice? if not what other references would be expected to approve this claim?


  • Data on file would be acceptable for a claim about “# of patients treated with drug/device X worldwide”. Likewise, availability in X countries could be supported by data on file. Note that these claims should not be linked to or suggest safety or efficacy.