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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Monthly Archives: November 2017
We have no sooner gotten rid of the candy from Halloween then we are preparing to receive our Thanksgiving guests and putting together menus for the big day, only to rush headlong into the next holiday season that will involve … Continue reading
There has been a huge push in policy circles to speed innovation in medicine which is manifest in several initiatives, including most notably the 21st Century Cures Act implementation. But it would be a mistake to assess the quickening pace … Continue reading
Phew – candy handed out and leftovers gobbled up at the office. I am safe. Now comes the rather heavy preparation for Thanksgiving to receive guests and prepare feasts. That, combined with extreme business foreclosed an intermediate posting this week … Continue reading
We are finally about to Fall Backward! Don’t forget to set your clock back this weekend to mark the end of Daylight Savings Time as we once again return to dark early evenings and even in December – dark late … Continue reading
The Office of Prescription Drug Promotion (OPDP), once known as the Division for Drug Marketing, Advertisting and Communications (DDMAC) monitors company communications about medical products and when it deems those communications have gone outside regulatory parameters, the office issues a … Continue reading