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 Submits Comments to HHS OIG on Proposed Revisions to AKS Safe Harbors; AMCP to Comment on White House Proposal to Allow Drug Importation; FDA Issues Draft Guidance on Interchangeable Insulin; AMCP Invited to Participate in Pharmaceutical Quality Workshop
January 2020 News & Views. Read articles on: AMCP Releases Format for Formulary Submissions, Version 4.1; 2020-2021 AMCP Board of Directors Announced; CEO Cantrell Previews 2020 Priorities; AMCP Forum Seeks Modernized Specialty Drug Benefits; JMCP Marks 25th Anniversary in 2020; Members in Florida Establish Latest AMCP Affiliate; Legislative Days Student Scholarship; AMCP 2020 to Present Six Education Tracks Covering Hottest Topics
As a new decade dawns, AMCP is preparing for the twists and turns of an uncertain first year. With health care a top issue in this year’s presidential campaigns, drug pricing a favorite target, and biosimilar use poised to expand, seeing where this year will lead requires much more than “2020” vision.
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).
Trump Administration Issues Proposed Rule Allowing Importation; House Passes H.R. 3 Drug Pricing Bill on Party-Line Vote; AMCP Submits Letter to House on 21st Century Cures 2.0; Stephen Hahn, MD, Confirmed as New FDA Commissioner; FDA Issues Draft Guidance on Interchangeable Insulin