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: August 2018
Weekly Roundup 8.24.18
This is it. We are in the home stretch. Summer, at least the one defined by the school year, is almost over. Even though it is many years for me that I have been ruled by that calendar, it will … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 8.24.18
Mid-Year Check on the Pace of New Drug Approvals at FDA
At the mid-year point, I usually do a check-in to see how we are doing on new drug approvals and how it compares to years gone by. I am quite tardy checking in on that front, so let’s get it … Continue reading
Posted in FDA Policy Comments Off on Mid-Year Check on the Pace of New Drug Approvals at FDA
Weekly Roundup 8.17.18
The vacation continues here in Washington, D.C. Traffic is lighter than a feather. Heat and thunderstorms continue and some of the leaves on trees have had it and are falling early, not in autumnal fashion, but as dried up little … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 8.17.18
Weekly Roundup 8.10.18
The summer creaks onward. In less than a month it will be Labor Day. I don’t know about you, but I find that almost incomprehensible. The folks on Capitol Hill are gone, which makes traffic here almost bearable. We like … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 8.10.18
Weekly Roundup 8.3.18
This week’s posting about FDA Communications resulted in a nice story by Ed Silverman over at STAT and some Twitter action from the Commissioner about the role of the “Statement from FDA Commissioner” missives that I wrote about. Fun stuff. … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 8.3.18