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By Timothy Shea
On November 26, 2010, the European Medicines Agency released its proposed guideline for regulatory approval of similar biological medicinal products containing monoclonal antibodies ("Guideline").
By Timothy Shea
On November 2 and 3, 2010, the FDA 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.
By Peter Jackman
The USPTO announced this week an expansion and extension of the Green Technology Pilot Program.