About the AuthorMy 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.
My ProfileI 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: April 2013
Weekly Roundup – 4-26-13
The spring clothes are headed to the closet, while the winter clothes are headed to their space for their seasonal slumber until next Fall. The days are sunny. The winter mess in the yard has been cleared away (mostly) and … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 4-26-13
Warning and NOV Summary – 1st Quarter 2013
Each quarter I regularly try to provide a little insight into OPDP’s current thinking as expressed through the issuance of Warning and NOV letters. What we saw last year is that the number of such letters after rising a bit … Continue reading
Posted in Warning Letters Comments Off on Warning and NOV Summary – 1st Quarter 2013
Weekly Roundup – 4-19-13
It has been a really busy week with travel and work that last Friday I didn’t even get to the Weekly Roundup. The schedule has been so busy, leaving no spare time for either posting here on the blog or … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 4-19-13
Weekly Roundup – 4-5-13
The daffodils are up and being rounded up in bunches and slipped into vases around the house, spreading good cheer, but overall Spring is still seemingly quite shy though indications are that is about to change. It is perhaps a … Continue reading
Posted in Warning Letters Comments Off on Weekly Roundup – 4-5-13