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.
Monthly Archives: March 2006
The Latest Skinny on Vitamins
Yesterday Robert E. Brackett, Ph.D., Director of the Center for Food Safety and Applied Nutrition for the FDA testified before the House Committee on Government Reform. The purpose of the hearing was to review the consumer safeguards surrounding the regulation … Continue reading
Posted in DSHEA, Vitamins and Supplements
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Minority Enrollment in Clinical Trials
When I worked at AIDS Project Los Angeles, I had a wristwatch with the organization’s name on it. Once when I was being examined by a heterosexual physician, he glanced at my watch and immediately asked why I had it … Continue reading
Posted in Clinical Trials, Minorities
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More on Plan B Politics
By the way, after last week’s posting on whether or not the FDA has a Plan B for Plan B, I came across proposed legislation that is actually titled "Plan B for Plan B" and has been introduced in the … Continue reading
Posted in FDA Policy
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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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Lessons for a New Regulatory Era, Part 2
Risk management is an iterative process, as the FDA likes to say. There are a broad spectrum of activities that comprise efforts at managing risk. There is the product labeling and within that there is the Black Box Warning (see … Continue reading
Posted in Regulatory Communications
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