[ebook] Version 4.1 of the AMCP Format: Product Dossiers

On December 23, 2019, the Academy of Managed Care Pharmacy (AMCP) released Version 4.1 of the AMCP Format for Formulary Submissions. This new version of the AMCP Format describes three types of dossiers that manufacturers may choose to develop:

Unapproved Product Dossiers provide information about a product that is not currently approved by the United States (US) Food and Drug Administration (FDA).2 Manufacturers may use these dossiers to provide information about a product to healthcare decision makers (HCDMs) prior to FDA approval.2

Approved Product Dossiers present information about a product that has been approved by the FDA.2 Manufacturers may use these dossiers to reactively provide information about a product to HCDMs in response to an unsolicited request after FDA approval.2

Unapproved Use Dossiers contain information about a product that is currently approved by the FDA.1 However, this information focuses on a currently unapproved indication of the approved product.1 Manufacturers may use these dossiers to inform HCDMs about an unapproved use of an approved product prior to FDA approval of the unapproved use.2

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