Archive for the 'Guest Content' Category

Generic Biologics: How to Compete

Posted by on 26th February , 2008

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 [...]

Posted in General Biotechnology, Guest Content, customer focus, drug interactions, exclusivity, generic biologics, healthcare providers, marketplace leadership, patient population, regulatory approval, return on investment, sales and marketing | No Comments »

FDA Enforcement Trends: 2007-2008

Posted by on 10th December , 2007

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 [...]

Posted in General Biotechnology, Guest Content, compliance, enforcement priorities, fda enforcement, food and drug administration fda, litigation, regulatory enforcement, unapproved drugs | No Comments »