AMCP Format for Formulary Dossiers Series – What’s in an Approved Product Dossier? Section Two

The contents of the Approved Product Dossier do not change in the new AMCP Format for Formulary Dossiers, but there is so much to talk about with this type of dossier, so we will be covering it section by section in the coming weeks.

Section 2 is one (or the) longest section in any dossier, so this week’s PDF is very long. Section 2 includes the product description, comparison to other similar products, the place of the product in therapy, disease description, approaches to treatment, and information about accompanying companion diagnostic test (CDTs, if relevant).

AMCP Format v4.1 Posts_AMCP_Approved_Section 2

Follow our page to keep up with all of the sections of the new AMCP Format for Formulary Submissions. If you need any assistance with creating or updating your dossier, let us know: 877-477-0977 or

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