On August 8, 2017, Sanofi-Aventis (“Sanofi”) filed a patent infringement suit in the United States District Court for the District of...
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Guidance
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The U.S. Senate passed S.934 – FDA Reauthorization Act of 2017 on Thursday, August 3, 2017, by a 94-1 vote after having been passed by...
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H.R.2430 – FDA Reauthorization Act of 2017, a bill reauthorizing all of the U.S. Food and Drug Administration (“FDA”) user fee...
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The Biosimilar User Fee Act (“BsUFA”) was originally enacted in 2012, and the current legislative authority is set to expire at the end...
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Introduction The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval pathway for biological...
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On January 12, 2017, FDA released its long-awaited final guidance on naming of biologics and biosimilars, entitled “Nonproprietary Naming...
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