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: December 2006
TIME Magazine has come out with it’s Person of the Year. It is You. Not just You, but the use of the Internet. The magazine, a print magazine, is signaling that there has been a shift in the way we … Continue reading
The 109th "Do Nothing" Congress has called it quits. They are headed into the sunset. But before they left, there was a lot of last minute bill-passing to make up for their lack of drive during the past two years, … Continue reading
Yesterday, the FDA held an advisory committee meeting on the labeling of anti-depressants in adults. I was not present, but heard coverage of the meetings on National Public Radio. There was wrenching testimony by those who have lost loved ones … Continue reading
Back in the 1980s when the HIV epidemic was sweeping through large cities and there were few treatment options available, there was a great deal of agitation at the grassroots level for the FDA to reform the process and do … Continue reading
As reported earlier this week, S.3546 – the Dietary and Supplement and Nonprescription Drug Consumer Act was passed by the Senate on December 6. Subsequently, on December 9, the House passed the Bill by a 2-1 majority. A few minutes … Continue reading