The contents of the Approved Product Dossier do not change in the new AMCP Format for Formulary 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.
Section 5 can provide additional types of evidence and studies that did not fit into Section 3.0B, such as clinical practice guidelines, HTAs and systematic review, compendia, modeling, and pharmacoeconomic studies. Many dossiers only have information in a section or two of Section 5, but it’s available if there are other types of evidence to provide to health care decision makers.
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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