AMCP Format for Formulary Dossiers Series – What’s in an Approved Product Dossier? Section Six
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 have been covering it section by section in the past weeks.
The contents of Section 6 are pretty self-explanatory. It contains all of the references for the dossier, any economic models discussed in Section 5, a copy of the approved Prescribing Information, any patient information, and a Material Safety Data Sheet (MSDS).
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