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: January 2008
Impact of Approvable Letters 2007 – Part 2
Yesterday I posted about the impact of approvable letters and began by saying I have not yet been able to compare this year to other years, but my gut told me that it was a higher rate of approvables than … Continue reading
Posted in Approvable Letters
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Impact of Approvable Letters 2007 – Part 1
I do not currently have a way of counting and comparing the number of approvable letters issued over the past few years, but my gut tells me that 2007 was a banner year. I am currently compiling the 2007 list … Continue reading
Posted in Approvable Letters
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Stakeholders (or Steakholders!) and Cloned Food Products – When Safety Is Not Enough
Last week, the media carried reports stating that the agency was getting ready to announce that it was satisfied that the science regarding cloned food demonstrated no safety issues. It is really not clear what that means for the timing … Continue reading
Posted in FDA Policy, Food
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Election Resource
As we kick off the new year, we also kick off an election cycle. Accordingly, my colleagues in Public Affairs at Fleishman Hillard put together a handy little tool providing an overview of the election 2008 that I wanted to … Continue reading
Posted in Useful Resources
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Iowa – What Does it Mean for Healthcare?
People want change. Barack to the Future! Huckabee a Wannabe! Those are my slogans. Barack Obama and Mike Huckabee are the winners according to CNN at this writing. What does that mean for healthcare? In my analysis of the past … Continue reading
Posted in Current Affairs
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