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: October 2007
FDA Approves New Merck HIV Medication
Yesterday the FDA announced a new drug approval for the treatment of HIV. Bucking the FDA’s recent inclination to approvable letters, the approval of Isentress (raltegravir) brings a first-in-class treatment known as integrase strand transfer inhibitors to the armentarium of … Continue reading
Posted in Current Affairs
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Warning Letter Summary – 3rd Quarter 2007
Following last week’s chart displaying the quantitative overview of FDA’s DDMAC issuance of Warning Letters and Untitled Letters, I wanted to begin this week with a qualitative perspective on what those letters covered. Since there are so few letters, it … Continue reading
Posted in Warning Letters
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Less Equals More
Here is a brief update on the pattern of Warning Letters issued by DDMAC to companies for violations in promotion. As you can see, the numbers under the Bush Administration have seriously declined, as pointed out frequently here on this … Continue reading
Posted in Warning Letters
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Weekly Roundup – 10/05/07
Well, autumn inside the nation’s first-city is getting off to a difficult start, made more so by a complete lack of rain that makes it look as if they only autumn color is going to be brown. One can’t even … Continue reading
Posted in Weekly Roundup
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A Conversation with Jim Greenwood – BIO CEO and President
The newly passed legislation in Congress that will reform FDA and reauthorize the Prescription Drug User Fee Act for another five years is just one example of dynamic change that is occurring in the marketplace. This week, I was able … Continue reading
Posted in Podcast
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