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 2015
Weekly Roundup 10.30.15
If you are like me, you have raided – at least once – the stash of candy you have squirreled away to give out this weekend. It happens every year. I am weak. Fortunately, tomorrow they will arrive and take … Continue reading
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Weekly Roundup 10.23.15
There was no Weekly Roundup last week due to a confluence of circumstances, including the fact that it seemed a very quiet week last week when it comes to many of the things I watch. But this week, there was … Continue reading
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A Look Back at Regulatory Enforcement by Therapeutic Category
In past years, I have always provided quarterly updates of the Warning and Untitled Letters that the Office of Prescription Drug Promotion (formerly DDMAC) puts out, regulating the promotion of pharmaceutical products. However, with only one letter issued each month … Continue reading
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Advisory Committee – Vacancies and Transparencies
The FDA has a total of 33 Advisory Committees, 17 of which are focused on Drugs and 5 of which are focused on blood, vaccines and other biologics. For our purposes today, we are going to focus on those dedicated … Continue reading
Posted in Advisory Committee Prepapartion
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Weekly Roundup 10.9.15
The days are growing noticeably shorter. The autumn chill has made itself felt from time to time. The leaves look ready to do their turn. The garden is in want of a mulching. Pumpkins are expectantly perched on front porches … Continue reading
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