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.
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).
AMCP last week gathered a group of diverse health care stakeholders to discuss the challenges and opportunities of ensuring patient access to a category of emerging therapies known as “digital therapeutics,” which have the potential to treat a wide range of diseases and medical conditions.
