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Promotion of NOC/C materials
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We are working on a reprint carrier (to hold copies of the pivotal trial). The tool will also provide some overview of the trial. Wondering whether there were any limitations given the product has NOC/C status? Is it ok for the content to be aligned with the PM OR does everything that is displayed on the reprint carrier have to be included in the PM verbatim?
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Per the Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOCc “3. For NOC/c product advertising, studies and/or data which are not presented in the Terms of Market Authorization will not be accepted.” Please note that this does not state “verbatim”. However, it should be interpreted to mean that no data from outside of the PM can be presented.
