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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Legislative Tracking Tools
Monthly Archives: April 2015
FDA Press Releases – 1st Quarter 2015
Last year I began a new database that tracks the press releases of FDA as a way to see what news the agency is talking about and provided a year end look at 2014. Looking back at the quantity and … Continue reading
Posted in FDA Image, FDA Policy 2 Comments
Weekly Roundup 4.24.15
It is that time of year when the temperatures can range by 30 degrees from morning until afternoon. The pollen counts are high and already sudden storms appear on the horizon to dump a lot of rain and then move … Continue reading
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Weekly Roundup 4.17.15
A few weeks ago it snowed, this week the lawn mowers were revved up. The car is covered in pollen. The cherry trees in DC have peaked. The ranks of tourists have swollen. Taxes have all been done and filed … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 4.17.15
Warning and NOV Letter Summary – 1st Quarter 2015
In the years past when the Office of Prescription Drug Promotion (OPDP) issued Warning Letters (WL) and Notice of Violation (NOV) letters with regularity, it was the custom here at Eye on FDA to review them on a quarterly basis. … Continue reading
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