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. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
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: DSHEA
On February 4, Senator John McCain introduced S.3002 entitled the Dietary Supplement Safety Act of 2010. If anyone wants to introduce a topic where there should be bipartisan support, this is it. In prior sessions of Congress, Senator Dick Durbin … Continue reading
With proposals before Congress (see Legislative section to the right) to allow the FDA additional power to regulate the industry of vitamins and supplements, there have been recent developments of note. Last week, the National Institutes of Health held a … Continue reading
Yesterday Robert E. Brackett, Ph.D., Director of the Center for Food Safety and Applied Nutrition for the FDA testified before the House Committee on Government Reform. The purpose of the hearing was to review the consumer safeguards surrounding the regulation … Continue reading