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: May 2010
FDA’s Generic Drugs – FDA Tracker Status Update
A month ago I was able to sit down with FDA's Deputy Commissioner Dr. Joshua Sharfstein to discuss the FDA's new effort at transparency and accountability called FDA Tracker, resulting in a podcast on the subject. FDA Tracker is a … Continue reading
Posted in FDA Policy, Generic Drugs
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A New Vector for Reporting Safety Issues is Launched
Yesterday, the FDA and the NIH announced the availability of a new electronic portal that has been partially constructed to allow widespread reporting of safety concerns for a huge array of products. It is a one-stop-site to report just about … Continue reading
Posted in Uncategorized
1 Comment
Anti-Incumbency Fever and the FDA’s Future
Last night came and went, bringing with it what anyone who watches politics pretty much expected. The country is in a mood of "out with the old, in with the new". It is Spring and the electorate is cleaning (the) … Continue reading
Posted in FDA Policy, Politics
1 Comment
i-Pad Checkup – Where Are the Healthcare Apps?
It has been a few weeks now that I have had my 3G -i-Pad. Sadly, I haven't had as much time with it as I would have liked, because I've been very busy with that stuff called work. But what … Continue reading
Posted in New and Social Media
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Webicina Launches Advisory Board
It is said that when you travel in space (I have not had the pleasure), even though you may be travelling at a great speed, you wouldn't see stars whizzing by and in fact, you might look out the window … Continue reading
Posted in New and Social Media
1 Comment