While there are some similarities between the sections in the Approved Product Dossiers and the Unapproved Product and Unapproved Use Dossiers, there are many differences. Section 1 provides a different experience in the Approved Product Dossier than the Unapproved Product and Unapproved Use Dossiers because of the limited data that can be shared before a product is approved. Sections 2 and 3 in all dossiers have similar headings and information, but Sections 4, 5, and 6 don’t even exist in the Unapproved Product and Unapproved Use Dossiers.
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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