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: March 2018
It is hard to believe, but we have completed the first quarter of 2018. Time is flying. Spring is springing. And we are the cusp of the commencement of another election cycle. It has been another busy week without a … Continue reading
Well Spring happened. Sorta. At least here in the East the first full day of Spring came with a winter storm warning for several inches of snow. Here in Washington, D.C. this coming weekend marks the beginning of the Cherry … Continue reading
The calendar says that it will be Spring next week, but it did not feel like it to me while working in the cold, windy and rainy garden in the days leading up to this change in season. However, it … Continue reading
There would seem to be a momentum for new approvals brought on by a number of circumstances, not the least of which is the fact that last year saw a record number (47) of approvals for new molecular entities (NMEs), … Continue reading