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.
Monthly Archives: September 2017
Today marks the beginning of autumn and the summer of 2017 is over. The first turning of trees has begun and leaves and acorns are dropping on lawns. The linens have left our closets and we are beginning to think … Continue reading
In this third, and final installment on new directions for FDA under the watch of a new Commissioner, we turn to the issue of opioids. When Dr. Robert Califf was being considered for confirmation as FDA Commissioner he faced a … Continue reading
One season winds down, another offers hints of a beginning. I am afraid that both the regular Weekly Roundup as well as regular postings have lately been interrupted by some domestic issues that came up for me as well as … Continue reading