The contents of the Approved Product Dossier do not change in the new AMCP Format for Formulary Dossiers; it’s more about the fact that it has a new name to differentiate it from the Unapproved Product and Unapproved Use Dossiers. But there is so much to talk about with this type of dossier, so we will be covering it section by section in the coming weeks.
In Section 1, the information provided is almost identical to the previous version of the Format for Formulary Dossier (v4.1). Its purpose is that of any executive summary, summarize what’s in the larger document for someone not deeply involved who needs to know at a high level why to choose this product over another to treat a certain population with a certain disease.
Follow our page to keep up with all of the sections of 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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