About the Author
My 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.Stay Connected
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I 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 Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York 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: August 2010
What Type Meeting Are You? A B or C?
This post is both interesting and boring at the same time. Sorry about that. I read, however, a release by a company about its product under development that stated in the headline that the company was seeking a "Type B" … Continue reading
Posted in FDA Policy
1 Comment
Roche Publishes Social Media Principles
The wrestling match in the development of social media guidelines is not confined to the health care industry, but as a highly regulated sector, there are some serious considerations for companies vis a vis social media. Direction is hard to … Continue reading
Posted in New and Social Media
1 Comment
A Look at FDA’s Transparency
When Ed Koch was mayor of New York, he'd often ask a crowd "How am I doin?" If you are in a position of authority, it isn't a bad question to ask every now and then, as long as you … Continue reading
Posted in FDA Policy
2 Comments
More Warning and NOV Letters to Come?
Everyone has noticed the uptick in Warning Letters and NOV letters coming out of DDMAC these days and written about several times over the past year on this blog. In case you haven't, here is an updated chart where I … Continue reading
Posted in Warning Letters
2 Comments
Tap, Tap, Tap … Waiting for an Alzheimer’s Test? A Spinal Tap Test Emerges.
A headline that has been both craved and feared appeared yesterday: "Spinal-Fluid Test is Found to Predict Alzheimer's" The New York Times reports that the Archives of Neurology is today publishing a study on a test for Alzheimer's that is … Continue reading
Posted in Current Affairs, Research
1 Comment