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: May 2008
DTC in the Crosshairs on the Hill
The House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations held a hearing this morning entitled "Direct-to-Consumer Advertising: Marketing, Education or Deception?" This is further evidence that as the election cycle heats up the Congress is quite likely … Continue reading
Posted in DTC Advertising
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FDA Issues Another Approvable Letter
This time, the letter was directed to Astellas, and it isn’t the first one. According to an Astellas press release that was issued today, the company stated that it received an approvable letter for its NDA for FK 506 Modified … Continue reading
Posted in Approvable Letters
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Weekly Roundup – 05/02/08
I am having a great deal of trouble wrapping my head around the fact that it is May, but look out the window and there it is. Inside the Beltway, we start counting down to the next Congressional recess, so … Continue reading
Posted in Weekly Roundup
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Most Recent Heparin Hearing
Here is some footage of the Heparin meeting from this week where it was stated that the contamination of Heparin would appear intentional. Note: If you are a subscriber you will have to visit the Eye on FDA site to … Continue reading
Posted in Crisis Communications, Current Affairs
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