In an Unapproved Product Dossier, the information in some of the sections is different than what’s included in those sections in an Approved Product Dossier. Because the product is not approved by the US Food and Drug Administration yet, these dossiers should NOT provide value propositions or conclusions/characterizations about safety and effectiveness. Without the same level of data on a product, this type of dossier is much shorter.
Check back for more information on changes in 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 https://medcommunications.com/contact-us/
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