Navigation

    Forum

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

    321 - A patient information brochure will NOT mention the product but will bear the name of the manufacturer. It will be distributed by the rep to the requesting health care professionals. Will this still need PAAB review?

    FYI post-approval change/preclearance exemption/what requires review/PAAB scope
    1
    1
    63
    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.
    • Jennifer Carroll
      Jennifer Carroll last edited by

      A patient piece generated by the manufacturer or its agent requires PAAB review unless both of the following conditions are met: there is no discussion of drug therapy (by product, class, or category) there is no discussion of drug issues (e.g. adherence to medication, potential implications of product ingredients…etc )

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