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. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
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: June 2010
Risk has grown exponentially in the world of food and drugs. Today we probably have more food coming into the US from more places than ever before. We have oil spills threatening the Gulf food supply. We have more … Continue reading
In May of last year, the Food and Drug Administration sent a Warning Letter to General Mills about a box of Cheerios. The problem? The FDA read the Cheerios box and didn't like what they saw when it came … Continue reading
For some time now, I've been an advocate for the use of video to complement work related to clinical trials. There are a lot of reasons for that, many of which I've stated before. Clinical trials are a bit of … Continue reading
Forgive me, it has been a while since we've gone out and had a round up of the week's news. What can I say? This is the Spring that totally got away from me. Last week alone I sat in … Continue reading
In what had to be one of the most non-newsworthy headlines to come out of FDA in a long time, this week the agency announced "FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals" which naturally raises … Continue reading