Webinar: Navigating Pre-approval Information Exchange (PIE) and the AMCP Format for Formulary Submissions, Version 4.1

By Xcenda |

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. Food and Drug Administration (FDA).

This webinar will provide an overview of pre-approval information exchange (PIE), review the changes and discuss the implications of the recently released AMCP Format v4.1, and provide manufacturer considerations and recommendations for PIE and the pre-approval dossier.