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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What Happened. This week FDA issued a new final guidance related to communications about medical products that, while representing a slight liberalization of regulation when it comes to discussing useful information about a drug and the cleared uses for it, … Continue reading
This week the Commissioner issued a statement related to the proposed modernization of the FDA’s drug review office, also the subject of a blog post by FDA’s head of the Center for Drug Evaluation and Research Janet Woodcock. While focused … Continue reading
While not the official one, the summer I knew as a kid – the one beginning after Memorial Day – has arrived. Officially I guess we have to wait a few more weeks. Once again a week without an intervening … Continue reading
It is Memorial Day Weekend! The opening bell for summer vacations has arrived. It is time to do your wardrobe switch – get out the white shoes, sandals and linen clothing and put the corduroys away until Labor Day. Time … Continue reading