One big change in the new AMCP Format for Formulary Submissions is an addition of two different types of dossiers and new terminology to describe them. The “traditional” dossier that is currently used for FDA-approved products is called an Approved Product Dossier in version 4.1, and the two new types are Unapproved Product Dossiers and Unapproved Use Dossiers. Manufacturers can now provide health care decision-makers with information on products before they are released through the Unapproved Product Dossier, and they can provide information on new indications for existing products through the Unapproved Use Dossier.
These new types are similar in how they differ from Approved Product Dossiers. Both new types allow manufacturer discretion on how these dossiers are provided to health care decision-makers and whether any economic value information is provided. Neither of the new types should provide value propositions or conclusions/characterizations about safety and effectiveness.
Stay tuned for more updates about the new AMCP Format for Formulary Submissions. If you need any assistance with your dossiers, let us know!