The two biggest differences between versions 4.0 and 4.1 of the dossier formats are the addition of the new types of dossiers (discussed in previous posts), and the importance placed on bidirectional feedback between HCDMs and manufacturers.

Though the discussion of bidirectional feedback is only about 1 page of the 91-page AMCP Format for Formulary Dossiers document, it was mentioned 3 different times in the webinar provided by AMCP on 1/28/20. The document shared with this post provides some of the recommendations for HCDMs and manufacturers in order to enhance the quality of dossiers. While the AMCP Format for Formulary Dossiers provides advice for enhancing communications between HCDMs and manufacturers, the document also asks them to consider how they might implement other ways to increase communications to improve transparency and the quality of information sharing.

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!

#AMCP #dossierwriting