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.
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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Monthly Archives: September 2009
The summer has ended. On Capitol Hill, however, the hot air continues to blow and blow hard regarding legislation aimed at reforming health care in the United States. Autumn has arrived and the time has come to plant the mums. … Continue reading
According to FDA: 1) Go to www.regulations.gov 2) Search for docket FDA-2009-N-0441-0001 (or type "Internet promotion" in the search box) 3) The search results will display the FR notice and under the "Actions" column on the far right there are … Continue reading
With the best of intentions, I set out to live blog from the FDLI Conference. While Day 1 did not afford me an electrical outlet or a dynamic laptop battery, the second day I successfully planted myself next to an … Continue reading
I had planned on live-blogging from the conference, but there was a paucity of electric outlets at the venue and my battery was exceptionally lazy. Following her speech, during question and answer, I asked Dr. Woodcock the question that was … Continue reading