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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Category Archives: Current Affairs
People are looking for black and white answers about what government agencies in general are going to do during the shutdown respecting specific operations. One of the specific areas of interest at FDA has been whether or not there will … Continue reading
It would seem like an obvious challenge to write for a blog called Eye on FDA when in fact, there is a government shutdown. That said, an agency that regulates one-quarter of the U.S. economy does not come to a … Continue reading
While not a news breaking blog, when interesting and timely information comes my way – it is for the sharing. This from my colleague Kip Piper of The Piper Report. This is, of course, in the event that the Congress … Continue reading
On September 17, 2013, the Office of Management and Budget (OMB) sent out a memo advising federal agencies to begin preparing for a government shutdown. Once again, as in the Spring of 2011, we are faced with the question of … Continue reading