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: December 2010
FDA Publishes Guidance Agenda for Coming Year
On Tuesday the FDA published the Guidance Agenda for the agency for 2011 in the Federal Register. It is important to note that the agenda is more of a Guide to Guides and is not a hard and fast schedule. … Continue reading
Posted in Uncategorized
1 Comment
YouTube, Me Tube, We all Tube
Another pharmaceutical company has joined the ranks of YouTube. Yesterday, the Twitter feed for Amgen announced the launch of their new channel. “#Amgen’s new YouTube channel is live!” it said. When you go to the channel, there are three videos … Continue reading
Posted in New and Social Media
5 Comments
Various Thoughts on FDA, Social Media and the Draft Guidance
As the year is rapidly coming to a close, many are wondering – where is the FDA on the Internet and Social Media Draft Guidance that was promised? It has been a long time since the FDA first enunciated anything … Continue reading
Posted in FDA Policy, New and Social Media
3 Comments
Weekly Roundup – 12/03/10
Cold has blown its way in, not only here but in Europe for sure. We have experienced a week with one foot still in the Thanksgiving holidays, perhaps clearing out the guestroom from our guests, using up or disposing of … Continue reading
Posted in Uncategorized, Weekly Roundup
2 Comments
Eye on FDA Hits a Milestone, Gets a Facelift
Eye on FDA has reached two milestones. The idea for the blog and the early work on it began five years ago this month. And this month, I am hitting my 1000th post. Like much of social media, blogging activity … Continue reading
Posted in About Me
4 Comments