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    Definition of a pivotal trial

    Claims & Support/References for Claims
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      Username last edited by

      Hello, could you please provide a brief explanation of what constitutes a "pivotal" trial, as this term is widely used but does not appear in the PAAB code? Thank you.

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

        Happy Friday @username

        The PAAB interprets “pivotal trial” to mean that the study was important to this specific product getting the indication (not necessarily important to the therapeutic area overall).

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