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 2012
I have been super-busy, as you may have discerned from my recent lack of correspondence here. But I am not alone! Things have been hopping from the FDA perspective, and here are a few things that occurred this week that … Continue reading
The Associated Press reported this weekend that FDA officials have expressed intent to investigate the marketing of an inhaled caffeine product. The product, called AeroShot, is described as a fine powder that is in a lip-stick type of tube … Continue reading
Each quarter Eye on FDA provides a brief recap of the regulatory action letters issued respecting the promotion of prescription drugs. The office that issues the letter underwent a change during 2011, changing its name in the process from the … Continue reading
Another snowless week, even when snow was predicted leads one to speculate that the daffodils, pushing their heads up so early, might not bloom just in time to have their heads poking up in a freakishly late blizzard. Meanwhile Valentine’s … Continue reading