About the AuthorMy name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in Washington D.C. 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.
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 BlogEye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. 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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Author Archives: Mark Senak
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
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
A personal note – Apologies – I have been lagging on postings following a bereavement. As each quarter ends, it has been an Eye on FDA practice to look back and compare different types of activities to assess any changes … Continue reading
Happy Friday the 13th, one of two for this year. Don’t worry, the other one happened already in April. I have been out on vacay for a bit, along with many I think. But back at the grind now and … Continue reading