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.
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 BlogEye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. 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 2015
2015 is already 1/12th over with. Frightening. A winter storm came and went from the East Coast. Here in Washington, we are still waiting for our first serious snowfall and it is not yet on the horizon. We are done taking … Continue reading
It seems 2015 is moving even faster than 2014 as we prepare for the last week of January even though it feels as if the holidays were only last week. It has been that time of year for reflection, looking … Continue reading
Earlier this month, I had posted about the steep decline in FDA’s OPDP enforcement rates as the number of Warning and Untitled letters for 2014 hit a new low of only ten for the year. In the posting, I had … Continue reading
It is a three-day weekend! Granted we just had the holidays, but they are very filled with exhausting activity – decorating, receiving guests, being a guest, wrapping. We need some recover time and in the spirit of the weekend, to … Continue reading
Last year, Eye on FDA had a posting that examined the press releases of the previous year, relying on a new tracking system I had implemented for that purpose. This being the second year of the database, we can not … Continue reading