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The Biologics Price Competition and Innovation Act of 2009 (the BPCI Act), 美利坚合众国
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版本年份
2010
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生效:
2010年3月23日
议定:
2010年3月23日
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The ‘Biologics Price Competition and Innovation Act of 2009’ (BPCI) was enacted as part of the 'Patient Protection and Affordable Care Act of March 23, 2010,' under the Subtitle A—Biologics Price Competition and Innovation of TITLE VII—IMPROVING ACCESS TOINNOVATIVE MEDICAL THERAPIES. The BPCI Act creates an abbreviated licensure pathway for biological products shown to be bio-similar to, or interchangeable with, an FDA-licensed biological reference product (See Section 7001 through 7003). This Text contains only the BPCI Act part, and the access to the full version of the Law is available from the 'Patient Protection and Affordable Care Act, of March 23, 2010.'
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The Biologics Price Competition and Innovation Act of 2009 (the BPCI Act)
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WIPO Lex序号
US385