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.
The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) was established to address anticipated needs for post-marketed evidence generation for novel biologics, their corresponding biosimilars and other related products.
Today, the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) announced that it has received a major grant from the Food & Drug Administration (FDA) in support of biosimilars research. The award provides $1.3 million over two years for a new BBCIC study focused on increasing the efficiency of biosimilar drug development and review.
On August 4, the Department of Health and Human Services released a Notice of Proposed Rulemaking on Nondiscrimination in Health Programs and Activities. In response, AMCP submitted comments on September 29 which applaud the Department's goal to reinstate regulatory protections from discrimination in covered health programs and activities.
In this August 2022 webinar, join AMCP Policy & Government Relations staff for an overview of federal legislation, federal regulation, state legislation, and the federal election outlook.
The School of Pharmacy Relations Committee (SOPRC) hosted the first Fall kick-off call specifically for faculty advisors of AMCP School of Pharmacy chapters.
Hemophilia is a rare disorder in which the blood doesn't clot in the typical way because it doesn't have enough blood-clotting proteins (clotting factors). If you have hemophilia, you might bleed for a longer time after an injury than you would if your blood clotted properly.
