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 2013
OPDP Letters for Promotion of Investigational Compounds, Part 2
In my last posting, I provided an overview from my database of Warning and Untitled (NOV) letters data base that spans the years 2004 – present regarding FDA actions around communications perceived by the agency to be promoting an investigational … Continue reading
Posted in Warning Letters Comments Off on OPDP Letters for Promotion of Investigational Compounds, Part 2
Weekly Roundup – 8-16-13
Oh sweet summer! The tomatoes hang heavy on the vines, hopefully out of reach of greedy little critters. The peaches and plums are deliciously ripe. It is almost time to put in a second batch of basil to keep growing … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 8-16-13
OPDP Letters for Promotion of Investigational Compounds, Part 1
As many know, I have put together a data base for my use that tracks the letters sent by FDA’s Office of Prescription Drug Promotion (OPDP) since 2004 – tracking company, date, indication, product name, type of communications vehicle and … Continue reading
Posted in Warning Letters 4 Comments
Weekly Roundup 8-9-13
The Congress is gone, the humidity is back. All things considered, that is the way we prefer it. It is that time of year where the grass appears to have had it and we find ourselves dreaming of and longing … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 8-9-13