About the AuthorMy name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in Washington D.C. 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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Author Archives: Mark Senak
The leaves are falling around us and still no first frost. And we are just a few short days from the knocks at the door by young and sometimes not so young seeking sugar handouts while dressed in costume. If … Continue reading
The first frost on the pumpkin is not far away. The garden is beyond tired and leaves are filling the gutters. I find myself craving comfort foods and am anxious for that first fire in the fireplace. Time marches on, … Continue reading
In 2015, FDA experienced a banner year with respect to the number of novel drugs and biologics that were approved by the agency – 45 all told. Since then, the 21st Century Cures Act was passed with the goal, among … Continue reading
It is Friday the 13th – one of two this year (the first was in January) and we sit a few weeks away from Halloween. Pumpkins on porches this month, in pies next month. A few weeks ago you may … Continue reading