Navigation

    Forum

    • Register
    • Login
    • Search
    • Categories
    • Recent
    • Popular
    • Users
    • Groups

    Annotated references required if accompanied by confirmation letter by Med Dept?

    Claims & Support/References for Claims
    2
    2
    82
    Loading More Posts
    • Oldest to Newest
    • Newest to Oldest
    • Most Votes
    Reply
    • Reply as topic
    Log in to reply
    This topic has been deleted. Only users with topic management privileges can see it.
    • NatBourre
      NatBourre last edited by

      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?

      Jennifer Carroll 1 Reply Last reply Reply Quote 0
      • Jennifer Carroll
        Jennifer Carroll @NatBourre last edited by

        @natbourre

        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.

        1 Reply Last reply Reply Quote 0
        • First post
          Last post