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: May 2013
FDA “It Has Come to Our Attention” Letter on Medical App
There are Warning Letters, Untitled Letters, otherwise known as Notice of Violation Letters, and now there is the “It Has Come to Our Attention Letter”. I have to admit, I had not heard of this particular kind of letter before, … Continue reading
Posted in Medical Apps Comments Off on FDA “It Has Come to Our Attention” Letter on Medical App
Weekly Roundup 5-24-13
Yee Hah! Memorial Day weekend is upon us – and not a moment too soon. It is time for hectic Spring to ease into lazier days of Summer. I hope. As for me, it may seem that I have been … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 5-24-13
Weekly Roundup 5-17-13
It has been a busy May. From working in the yard to transform it from looking like property on which Boo Radley might have a house to putting on panel discussions and layers of business travel to grading papers and … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 5-17-13
Webinar on FDA Communications Oversight in a Digital Era
Many may recall that in early April, I released a paper I did here on Eye on FDA called “FDA Communications Oversight in a Digital Era” that examined the patterns of enforcement by FDA’s Office of Prescription Drug Promotion as … Continue reading
Posted in Warning Letters Comments Off on Webinar on FDA Communications Oversight in a Digital Era
Weekly Roundup 5-3-13
The grass is not greener on my side, mainly because it is mostly not there. The lawn, if you want to call it that, looks like it needs a lot of attention – probably more than I have to give … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 5-3-13