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: March 2008
After the inaugural posting, FDA Commissioner Andrew C. von Eschenbach has posted a first substantive note on his new space on the FDA Web site. One doesn’t know quite what to label "Andy’s Take". It is a sort of column … Continue reading
For a while now, I’ve been thinking about the growing number of drugs that are being approved overseas and going on the market overseas, but are not getting approved or are getting approvable letters in the U.S. It is a … Continue reading
Yesterday you were able to hear from a former FDA Commissioner Dr. David Kessler. Today, you can hear from the current commissioner. On the FDA Web site, a new element has been added called "Andy’s Take" and it is a … Continue reading
Last week, my employer – Fleishman-Hillard, held a public affairs briefing in Washington, D.C. that included several of the members of the International Advisory Board (IAB) for the firm. The event was co-hosted by the Capitol Hill newspaper Roll Call … Continue reading