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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Daily Archives: June 21, 2007
Wow – the approvable letters are flying off the shelves. If you are not familiar with approvable letters, see my posting "What Does Approvable Mean?" Or you may wish to listen to my podcast on the subject of approvable letters. … Continue reading
As you know, I am proponent of the use of feeds to spread information and have written frequently on the topic. Feeds are an extremely efficient method for disseminating news and conform to the way people are using the Internet … Continue reading
During the election for the office of president that pitted Jimmy Carter against Ronald Reagan, there was a famous utterance from "The Great Communicator" – "There he goes again…" said Ronald Reagan. Yesterday, President Bush used his veto power for … Continue reading