HealthyWomen, members of its HPV Coalition and additional stakeholders are writing the Advisory Committee on Immunization Practices (ACIP) regarding the upcoming June ACIP meeting June 25-27, 2025, docket number - CDC-2005-0024.
AMCP Comment Letter on Biosimilar Interchangeability with a Biologic Reference Product
On Aug. 6, AMCP responded to FDA’s draft guidance on considerations in demonstrating biosimilar interchangeability with a biologic reference product. The draft guidance, issued on June 17, describes considerations regarding switching studies which demonstrate interchangeability between biosimilars and their reference biologic products.
Related
Today, Senator Josh Hawley (R-MO) introduced legislation that would rollback some of the impending cuts to federal Medicaid funding as mandated by H.R. 1.
The Department of Health and Human Services (HHS) sent out an RFI. AMCP provided a response which aims to promote precision medicine through a reconsideration of the "14 Day Rule".
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