482 - Is it acceptable to use Data on File such as a PSUR to support non-clinical statements such as patient exposure? If so, what format should the Data on File take as it is not possible/desirable to provide the whole document as data on file. Thank you.

  • Non-comparative claims relating to number of patients who’ve taken your brand OR the cumulative number of years of use across all patients using your brand can be supported with an attestation letter from the manufacturer’s medical/regulatory department. If you have something else in mind, I suggest submitting a written opinion (see fee schedule on our website) which includes the relevant parts of the Periodic Safety Update Report and the precise claim you’d like to use that data to support.Per PAAB code s3.3, references cited in the APS must be available to health professionals on request, in English and/or French, either in their original form or translated. A copy of the summary of the Data on File must be provided to health professionals upon request.

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