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Fueling The BPCI Debate

  • 03.08.11
  • Timothy J. Shea
  • Law 360

On Nov. 2 and 3, 2010, the U.S. Food and Drug Administration held its first public hearing to obtain input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which established an abbreviated approval pathway for generic versions of biological products. This article, available only on law360.com, summarizes the key points for each of the issues that were raised at the hearings.

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