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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For some time there has been speculation that enforcement at FDA is up. But it should be noted that regulatory action letters come from several different parts of the agency and encompass much more than promotional communications. For our purposes, … Continue reading
Hello? Anyone out there? I send out a group email and get back scores of automated replies thanking me for my email and telling me when the recipient will be back in the office. I feel like the only person … Continue reading
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