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.Stay Connected
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I am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!About This Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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Category Archives: Weekly Roundup
Weekly Roundup 4.27.18
Another busy week that did not permit me time to get to some of the postings I have been working on between Roundups, but next week look for some. There has certainly been a lot going on and a lot … Continue reading
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Weekly Roundup 4.20.2018
In some recent postings, it has been noted that the FDA Commissioner has made liberal use of the vehicle of “Commissioner Statements”. Last month, there were 9 – on average 2 a week. Then suddenly this month, the entire first … Continue reading
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Weekly Roundup 4.13.18
For those of superstition, it is the first of two Friday the 13ths for this year. For the rest of us, we are assessing our bad luck with regard to the fact that if you live in the mid-Atlantic it … Continue reading
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Weekly Roundup 4.6.18
This has been a rather extraordinary year from an FDA perspective. Last year there were record approvals and a number of firsts. Advances in oncology have been eye opening to say the least. And on a policy front, there has … Continue reading
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Weekly Roundup 3.30.18
It is hard to believe, but we have completed the first quarter of 2018. Time is flying. Spring is springing. And we are the cusp of the commencement of another election cycle. It has been another busy week without a … Continue reading
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