Fueling The BPCI Debate

Law360, New York (March 8, 2011, 1:46 PM EST) -- 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.

According to the FDA, the purpose of the Part 15 hearing was "to receive information and comments from a broad group of stakeholders, such as health care professionals, health care institutions, manufacturers of...
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