Legislative History of the Biologics Price Competition and Innovation Act of 2009

Corporate Author:: United States
Additional Titles:: BCPI Act
Published:: [Cambridge, Mass.] : [Petrie-Flom Center], [between 2010 and 2017]
[Getzville, New York] : William S. Hein & Company, [2017]
Physical Description:: 1 online resource (12 volumes (various pagings)).
Additional Creators:: Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

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"The Patient Protection and Affordable Care Act (PPAC Act), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products that are demonstrated to be 'highly similar' (biosimilar) to or 'interchangeable' with an FDA-approved biological product. These new statutory provisions also may be referred to as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act)"--website of the U.S. Food & Drug Administration, "Implementation of the Biologics Price Competition and Innovation Act of 2009."

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