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: June 2007
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
As many of you know this is an intermittent series I’ve been writing on uses of new media by the pharmaceutical industry. So far, I’ve written about the use of Blog Monitoring, RSS Feeds for press releases and the use … Continue reading
On Sunday, two of the nation’s leading papers, the New York Times and the Washington Post both carried front page articles relating to the safety of medical products or components of medical products from China. The Times article, "FDA Tracked … Continue reading
On Friday, it was announced that Encysive Pharmaceuticals received a third approvable letter for its NDA for THELIN(tm) (sitaxsentan sodium), for the treatment of pulmonary arterial hypertension. At 8 AM Eastern Time this morning the company is holding a Web … Continue reading