About the Author
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
Category Archives: Safety and Clinical Trials
Is Congress the New FDA?
Given the dismal track record of the U.S. Senate in the 111th Congress in producing important legislation to improve the lives of Americans, it appears that some of that body's members are looking for new things to do. In the … Continue reading
Posted in FDA Image, Safety and Clinical Trials
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The New FDA Drug Safety Initiative – Policy and Communications Implications
Yesterday the FDA announced yet another new initiative on drug safety. This is apparently in addition to the pre-existing Drug Safety Initiative. It is an action taken in response to the Institute of Medicine (IOM) report – The Future of … Continue reading
Posted in FDA Image, Risk Management, Safety and Clinical Trials
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Tragedy in Britain – Magnifying the Risk in the Risk/Benefit Equation
By now you have probably heard the terrible story out out of the United Kingdom regarding six human volunteers in a Phase I study who became seriously ill almost immediately after taking a study medication. An analysis of the situation … Continue reading
Posted in Safety and Clinical Trials
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Where Do You Stand on Phase IV Studies?
Last week, there were reports that the FDA came out with its annual report on how drug companies are faring with respect to keeping their post-marketing study commitments. The report card was not so hot. A whopping 65% of the … Continue reading
Posted in Safety and Clinical Trials
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Considerations for a New Regulatory Environment
February 15, 2006 – This is a time for a lot of soul searching on the part of industry as well as the FDA. Events of the past two years are shaping an entirely new landscape in drug development and … Continue reading
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