Navigation

    Forum

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

    342 - In the development of booth promotional materials intended to reprise indications, contraindications, warning and precautions which are part of the Product Monograph, are there any restrictions on how these sections can be excerpted. Is is permissible to exclude text from the indications section, for example?

    Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
    1
    1
    51
    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

      The indication statement must be presented verbatim once in the APS per section 2.10 of the PAAB code. The other segments mentioned in your question need not be verbatim but they must reflect the essence of the product monograph. Please refer to the guidance documents on the PAAB website for requirements relating to fair balance format in drug advertising.

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