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: January 2007
The New FDA Drug Safety Initiative – Policy and Communications Implications
Yesterday the FDA announced yet another new initiative on drug safety. This is apparently in addition to the pre-existing Drug Safety Initiative. It is an action taken in response to the Institute of Medicine (IOM) report – The Future of … Continue reading
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The EMEA and the FDA
Last week, a report was issued by the Tufts Center for Drug Development that showed that while the European Medicines Agency (EMEA) – the European Union’s FDA equivalent – had met its performance goals, it was nevertheless lagging behind the … Continue reading
Posted in Miscellaney 3 Comments
Weekly Roundup 1/26/07
Already the first month of the new year draws to a close. We’ve heard about the State of the Union, such that it is. The days, thankfully, grow longer. And at the FDA, there have been another huge batch of … Continue reading
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Approvable Letter Issued to Wyeth
Following a rash of approvable letters at the end of 2006 for a number of products, Wyeth Pharmaceuticals announced that it has received an FDA approvable letter on January 22 for Pristiq (TM) – desvenlafaxine succinate – a serotonin-norepinephrine reuptake … Continue reading
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Warning Letter Summary for 4th Quarter 2006
A total of seven companies received Warning Letters during the last quarter, meaning that one-third of the year’s letters came in the final three months of the year. What we saw is a mix of large and small companies, with … Continue reading
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