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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Monthly Archives: June 2015
FDA Enforcement of Digital Communications – An Update
In 2013, I published a white paper called “FDA Communications Oversight in a Digital Era” that drew upon the data base I had put together of OPDP Warning and Untitled Letters (referred to collectively as “regulatory action letters”). The object … Continue reading
Posted in Social Media
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Weekly Roundup 6.19.15
No postings this week – sorry about that – travel and business, but will shoot for some good ones next week. This was another week of tropical rain – the kind that comes and dumps steady water as if a … Continue reading
Posted in Weekly Roundup
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Weekly Roundup 6.12.15
It is as if the calendar just knows when to turn up the heat. We have crossed over into the second week of June and already we face days that head into the 90s and late afternoon thunderstorms that characterize … Continue reading
Posted in Weekly Roundup
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Live Streaming – Game Changer for AdComms and Beyond?
This week there was a lot of talk about last week and the meeting of the American Society of Clinical Oncology annual meeting ASCO 15, which was the 51st annual meeting of the society held May 29 – June 2 … Continue reading
Posted in Advisory Committee Prepapartion, New and Social Media, Social Media
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Weekly Roundup 6.5.15
It has been a week of rain and gloom in our nation’s seat of government. It has been cold, gray and unpleasant. Commutes are nasty. The lack of sunshine is getting serious. But on the bright side, pollen has been … Continue reading
Posted in Weekly Roundup
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