AMCP Format for Formulary Dossiers Series – What’s in an Unapproved Product Use Dossier?
In an Unapproved Use Dossier, the information is similar to those sections in an Unapproved Product Dossier. There is some information included about the Approved Product, but this dossier should NOT provide value propositions or conclusions/characterizations about safety and effectiveness of the new use. There might be less economic information, as it might be similar to the Approved product and only anticipated changes in costs need to be explained.
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