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.
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: January 2018
As we ease into the new year cycle, 2018 is still waking up. Many of FDA’s web pages are not yet updated to reflect that the new year even exists. The weather is erratic, with low low temperatures one day … Continue reading
Having worked with a lot of companies to prepare for an FDA Advisory Committee (AdComm) , I track the activities of the committees in a database marking outcomes, votes and other characteristics. As part of a look-back series as we … Continue reading
Welcome to the first Weekly Roundup of the year! The fact that it was a short week and one in which the East Coast and a good deal of the South were experiencing a weather challenge means that there was … Continue reading