Posted by Michael Wonder on 08 Jan 2020
AMCP Format for Formulary Submissions, Version 4.1, includes new dossiers for submitting evidence on unapproved medicines and unapproved indications submitted for FDA approval
8 January 2020 - AMCP has released Version 4.1 of the AMCP Format for Formulary Submissions, which includes two new dossier types for biopharmaceutical manufacturers to share evidence on unapproved products and new indications that are under review by the U.S. FDA.
The first version of the AMCP Format was launched in 2000, and it has since become the primary tool manufacturers use to share safety, efficacy, and value data with health care decision makers (HCDMs) as they consider products for coverage and formulary placement.
Changes in the AMCP Format 4.1 are a direct response to growing information needs due to the complex and costly therapies coming to market each year.
