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 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
When Does FDA Extend a PDUFA Date?
Today Eisai Inc. issued a press release entitled "Eisai Announces Extension of FDA Review of Drug Application for Investigational Agent Eribulin Mesylate". The company sites the reason for the extension is "a result of the agency classifying recent responses to … Continue reading
Posted in FDA Policy, Tutorial 1 Comment
The Battle of the Bulge – New Guidances from FDA on Calories and Fast Food
Anyone who has ever sat in an airport waiting for a late flight – and who hasn't – may have noticed something disturbing while engaged in the healthy pursuit of people-watching. We are increasingly a nation of fatso's. Not long … Continue reading
Posted in Uncategorized 3 Comments
The Case of the Missing Advisory Committee Transcripts…..
Usually, I love a good mystery. And they are good summer reading especially. But this one is a bit perplexing. Whenever an advisory committee serving the Food and Drug Administration has a meeting, someone has the unenviable task of transcribing … Continue reading
Posted in Uncategorized Comments Off on The Case of the Missing Advisory Committee Transcripts…..
Weekly Roundup – 08/20/10
I have been temperamental on the Weekly Roundup lately. It is only a reflection of the fact that it has been an extraordinarily busy summer. I will persevere to be more faithful. In the meantime, here is a bit of … Continue reading
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