With the change to having three types of formulary dossiers in the new AMCP Format for Formulary Submissions, the numbering of the sections within each dossier changes to include an A, B, or C at the end of each section number (eg, 1.0A, 3.0B, 4.0C). The section headings stay essentially the same for the Approved Product Dossier, and the Unapproved Product and Unapproved Use Dossiers make use of the same section headings when appropriate. For example, all three types of dossiers have a Section 3 containing Clinical Evidence. The Unapproved Product and Unapproved Use Dossier have exactly the same sections, except that the Unapproved Product Dossier sections end with an A (ie, 1.0A, 2.0A, 3.0A, 4.0A) and the Unapproved Use Dossiers end with a C (ie, 1.0C, 2.0C, 3.0C, 4.0C).
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!