The formats for Unapproved Product and Unapproved Use Dossiers are new with the latest AMCP Format for Formulary Dossiers. Because manufacturers cannot make claims about an unapproved product or use, the Unapproved Product Sections Dossiers have a Highlights and Overview section instead of an Executive Summary detailing the clinical and economic value of the product, The recommended length of the Highlights and Overview section is 2 pages (4 pages max), and it is recommended that much of the information be presented in a Table Of Highlights. It is acknowledged that much of this information may not be available yet, but if it is, it should be provided, and if it’s later available, the dossier should be updated with it.
Check back for more information on changes in the new AMCP Format for Formulary Submissions. If you need any assistance with adjusting your dossiers to meet the new guidance, let us know: 877-477-0977 or https://medcommunications.com/contact-us/
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