On Jan. 20, 2025, newly inaugurated President Trump signed dozens of Executive Orders concerning a number of G.O.P. policy priorities, including but not limited to: immigration and border security, trade and economic policy, the federal workforce, energy and environmental policy, law and order, and social policies. While health care was not a primary focus of these executive actions, President Trump did withdraw the United States from the World Health Organization and revoked several Biden-era actions related to health policy. Executive Orders are directives from the president that manage operations of the federal government, have the effect of law, may be promulgated by government agencies, and may be overturned by judicial review if they lack support by existing law or the Constitution.
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On Aug. 6, AMCP responded to FDA’s draft guidance on considerations in demonstrating biosimilar interchangeability with a biologic reference product. The draft guidance, issued on June 17, describes considerations regarding switching studies which demonstrate interchangeability between biosimilars and their reference biologic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.
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