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    468 - Hi Patrick, my question is regarding the use of an economic impact study and doing a slide deck around it. Is this not PAAB exempt given that this is not about clinicals but cost savings?

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

      Assuming the slide deck relates to healthcare products and it is directed to HCPs, it would indeed require PAAB review. Refer to PAAB code s5.10.1.ii and the website document “Guidance on Pharmacoeconomic studies” for more information. See the resources tab on our website.

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