Prepublication Overview – AMCP Format for Formulary Submissions 4.1

AMCP will release Version 4.1 of the AMCP Format for Formulary Submissions in December 2019. It includes new sections describing the evidence needs of health care decision makers (HCDMs) for unapproved products nearing the end of the product development pipeline, as well as unapproved uses of existing products for which FDA approval is being sought.

Since its initial release in 2000, the Format has become the gold standard by which manufacturers submit the objective, credible, and relevant information required by HCDMs in their consideration of products for formulary placement. The new version continues AMCP’s legacy of providing tools that help ensure patients get the medications they need at a cost they can afford.

Read the full Prepublication Overview in the PDF below.