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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The mandate for protecting the public’s health at FDA has expanded dramatically, especially last year when the Food Safety Modernization Act (FSMA) was passed and signed into law, giving the FDA new authorities to inspect and initiate recalls of food … Continue reading
I was reminded as I tried to set up my new scale complete with WiFi that will feed into my iPad my weight, body mass index and with accompanying blood pressure cuff – my blood pressure. The app in the … Continue reading
Early last month, in the wake of the Apple announcement of changes coming to iOS-5, I wrote a posting about how the future might be impacted by cloud computing, increased access to Twitter and considerations around the mobile access to … Continue reading
Summer officially began. The days have, by seconds only, begun to grow shorter. Storms threaten on a nearly daily basis. Humidity is a constant companion. And today was the last day of school in my neighborhood making me happy once … Continue reading