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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Category Archives: Clinical Trials
“I am a cancer survivor, I was treated for cancer during my last tour at FDA, so I k now the importance of what American medicine does — and what the FDA does — for every one of us.” Scott … Continue reading
For a long time, I have thought that clinical trial information was too clinical to be of much use for patients who might be considering entering one. The information available was either in the form of searchable data bases, text … Continue reading
You are sitting in the doctor’s office on that crinkly paper that pops every time you move. Your physician is leaning against a table and has just uttered some words that were a diagnosis. It is a serious diagnosis. For … Continue reading
Today Adolor Corp. announced receipt of an approvable letter from the FDA requesting 12-month safety data that includes an analysis of any cardiovascular related adverse events. The application was for Entereg, indicated for the management of postoperative ileus. Share this: