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 ProfileEXPERTISE - 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; issues and crisis management. 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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My Favorite Dogs
The U.S. Pharmacopeia – What is it? What Does it Do?I had the pleasure of chatting with Dr. Roger L. Williams, CEO of the USP to talk about what the campaign is designed to accomplish and what it is that the USP actually does. There are two installments of podcasting here - the first which talks about what the USP does, and the second geared to the campaign itself.
FDA Pioneers New Level of Transparency – An Interview with Dr. Joshua SharfsteinI had the opportunity last Friday to sit down with Dr. Joshua Sharfstein, Principal Deputy Commissioner of the Food and Drug Administration to discuss FDA Track. We talked about the genesis of the program, how they are doing it, what those of us in the public who are interested can expect of the program, and the process and timeframe for bringing it entirely up and running. Check it out.
Category Archives: FDA Policy
For the second time in as many years, we have been going through the ritual of getting a new FDA Commissioner appointed. The last one – Dr. Robert M Califf served from February 2016 until January of this year. Dr. … Continue reading
Anyone who reads this blog knows that apparently I like to count things. Why? Well it provides the basis to confirm or refute general observations, and also can provide perspective that makes you stop and think and wonder. But if … Continue reading
In his remarks to a joint session of Congress delivered this week, President Trump expressed the point of view that the “slow and burdensome approval process at the Food and Drug Administration keeps too many advances… from reaching people in … Continue reading
During the campaign, candidate Donald Trump made several statements referring to the fact that he would be cutting regulation in this country by 70-80 percent. Since the election, that sentiment has been repeatedly affirmed. Now in office, this week he … Continue reading