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: February 2020
In June 1981 I graduated from law school. One month after that an article appeared in the New York Times with the headline “Rare Cancer Seen in 41 Homosexuals” on page A20. These two events would end up pretty much … Continue reading
There are a lot of important facts on the FDA’s Web Page set up to provide information about the novel coronoavirus (2019-nCOV) outbreak, now dubbed COVID-19. But there are three sobering statements that stand out: There are no FDA-approved diagnostics … Continue reading
There is a policy interest in driving the biosimilar market. Among other reasons, increasing the number of generic drugs and biosimilars on the market addresses another policy priority – having an impact on the high cost of medicine. The approval … Continue reading