Annotated references required if accompanied by confirmation letter by Med Dept?
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I realize we need a list of references for HCP-targeted information. Are we required to annotate the references if the medical department confirms in a letter that the content is accurate as per the references?
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All materials should be reviewed and approved by the manufacturer’s medical department prior to submission to PAAB as per the efile submission form and Code section 1.6B3. However, this does not negate the requirement to annotate the references to facilitate PAAB review of the APS against advertising regulations. Please see our new guidance document for the submission process for directions on referencing.
