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: November 2006
What the Freshman Offer
Hey there. My colleagues at Fleishman-Hillard and Fleishman Hillard Government Relations developed a wonderful overview of those incoming Congresspeople who have healthcare backgrounds. I wish I could take credit for it, but (sadly) I cannot. Still, it gives an insight … Continue reading
Posted in Current Affairs
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A Review of MedWatch Alerts
I did a tally of MedWatch alerts for the century. The table below only reflects those issued for CBER and CDER and does not take into account alerts issued about devices or supplements. The interesting thing is the scale and … Continue reading
Posted in FDA Policy
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Weekly Roundup – 11/10/06
Well, here we are at the end of an ironic week. On the one hand, we look back with a sigh of relief that the election of ’06 is over. On the other hand, we are now looking forward to … Continue reading
Posted in Weekly Roundup
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This is Your State… This is Your State on Drugs – An Intermittent Series
The nation’s eyes are glued to the change in Washington, or at least those inside the Beltway would like to think that you are. The House of Representatives switched, we have the prospect of the first woman Speaker of the … Continue reading
Posted in Current Affairs
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Post Election Vibe
It is hard not to write about what happened last night. It seems inherent that bloggers have to write about elections. The House moved into the Democratic aisle and Speaker-designate Nancy Pelosi is quoted as saying she would move for … Continue reading
Posted in Current Affairs
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