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Category: Guest content

Generic Biologics: How to Compete

February 26, 2008 Comments Off Posted in: General Biotechnology, Guest content

Guest content from John Avellanet, managing director and principal of Cerulean Associates: Follow-on biologics are a foregone conclusion in the US. Too much money is at stake. The more difficult discussion starts with how to prepare your company to compete. Science Succumbs to Dollars The financial pull on reimbursement organizations and the constituent push on […]

FDA Enforcement Trends: 2007-2008

December 10, 2007 Comments Off Posted in: General Biotechnology, Guest content

Guest content from John Avellanet, managing director of Cerulean Associates: The US Food and Drug Administration (FDA) intends to increase regulatory enforcement, extending the recent trend of laboratory and clinical site inspections to unapproved drugs and reformulations. How can you avoid compliance trouble? At the Food and Drug Law Institute’s 5th Annual Enforcement and Litigation […]