AMCP Format for Formulary Submissions – Guidance on Submission of Pre-approval and Post-approval Clinical and Economic Information and Evidence, Version 4.1

4/20/20

Due to the rapid pace of complex, high-cost therapies coming to market, Health Care Decision Makers (HCDMs) need to obtain information about these therapies sooner to consider and plan for these new products, thereby reducing or eliminating delays in patient access. To address this need, the AMCP Format Executive Committee began work in late 2018 to expand Format 4.0 to define information needs to support pre-approval assessments and budgeting.

AMCP Format 4.1 includes new sections describing the evidence needs of 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.

By defining those information needs, AMCP Format 4.1 provides recommendations that can be helpful for biopharmaceutical companies and other stakeholders involved in the preparation of product dossiers.

Read the full Format 4.1 in the PDF below.