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: March 2015
Weekly Roundup 3.27.15
Another busy week – hence a day late with the Weekly Roundup. This week, I cleared one of the flower beds of the dead stems from winter and filled three lawn and leaf bags with leaves and stems. They took … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 3.27.15
Is Bigger Safer? OPDP Enforcement Patterns and Company Size
Eye on FDA has frequently carried overviews and summaries of enforcement by the Office of Prescription Drug Promotion (OPDP) through the issuance of Warning and Untitled Letters (regulatory action letters). These letters, along with guidance documents that are occasionally issued … Continue reading
Posted in Warning Letters 1 Comment
Weekly Roundup 3.20.15
There really is more to Eye on FDA than the Weekly Roundup, but this month you wouldn’t know it. Busy schedule combined with a few health issues have resulted in a diminished output, hopefully to be put right now that … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 3.20.15
Weekly Roundup 3.13.15
On the road this week left little time for posting, though some interesting things happened. And meanwhile, back in Washington, D.C., the last vestiges of snow have departed and on my dog walk, I spotted blooming purple crocuses which was … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 3.13.15
Weekly Roundup 3.6.15
I found myself dreaming about picking herbs from my herb garden and thinking of expanding my efforts there this year to include new items. I imagined flowers blooming out on back deck. And these whimsical thoughts all occurred while I … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 3.6.15