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    PM comparisons of warnings & precautions

    PAAB Q&A
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    • K
      karen.taylor last edited by

      Our client would like to develop a tool that presents a text based side-by-side comparison from two product TMAs on instructions for use limitations (i.e. warnings & precautions). We understand that we have to make the comparisons representative of the section of the TMA that it is based on and not selective to which attributes are included, but a piece that presents the entire warnings & precautions section for each drug would be extremely long. We’re aiming to understand if we can make comparisons of just specific sub-sections of the W&P section (for example a sub-section under a “Cardiovascular” subheading, and then be complete about covering everything within that particular section for both products), versus having to include the entire W&P section?

      We would, of course, ensure that a disclaimer is included that denotes that clinical significant is not implied, and that there is no heading that implies an overall comparison of safety.

      Jennifer Carroll 1 Reply Last reply Reply Quote 0
      • Jennifer Carroll
        Jennifer Carroll @karen.taylor last edited by Jennifer Carroll

        Hey @karen-taylor

        Side-by-side presentations of warning and precautions across two or more product monographs should be a complete presentation of the entire section so as not to be selective, unbalanced or incomplete. Focusing on a subset of the warnings is essentially a safety comparison and safety comparisons are not permitted across monographs. They require head-to-head RCTs per s5.7.

        The way you make the presentation in question (warning and precautions across product monographs) something that can be considered, is by making it a complete comparison of the section of the PM.

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        • K
          karen.taylor last edited by

          Thanks @Jennifer-Carroll!

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