Pre-Approval Information Exchange

AMCP Format for Formulary Submissions, Version 4.1, Includes New Dossiers for Submitting Evidence on Unapproved Medicines and Unapproved Indications Submitted for FDA Approval

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).
Pre-Approval Information Exchange, Formulary & Utilization Management