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 2016
Once and Future AdComms Affecting Drug Applications
One area of FDA activity that I like to track is in relation to advisory committees which I think provide us with something of a surrogate marker for the pace at which FDA is considering and approving new drugs. To … Continue reading
Posted in Advisory Committee Prepapartion
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Weekly Roundup 3.25.16
Well the first quarter of 2016 has sure blown by. We had the earliest Equinox since the 19th Century. Someone flipped a switch and everything started blooming at once. The cherry blossoms got well underway this week. And here is … Continue reading
Posted in Weekly Roundup
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Patient Engagement Mainstreams
One Tuesday morning early in October in 1988, a large group of protestors appeared in front of the building that housed the Food and Drug Administration and effectively shut the agency down. There were hundreds of protesters present, organized by … Continue reading
Posted in FDA Policy
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Weekly Roundup 3.18.16
St. Patrick’s Day is behind us, Easter is before us. And yet, there is a forecast of snow for our area here in the mid-Atlantic looming before us for the weekend. Yes, it is that delightful time of the year … Continue reading
Posted in Weekly Roundup
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Testimonials – The Pitfalls
People like to get information from people they trust. Moreover, a hallmark of digital communications has been a turning away from large, institutionalized sources for information and turning instead to hear from individuals. Pew Research has shown that especially for … Continue reading
Posted in FDA Policy, Warning Letters
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