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: November 2016
New Directions for FDA, Part 1 – 21st Century Cures
One of the often stated priorities for lame-duck Congress has been voting on the 21st Century Cures Act. In a press release from Saturday, November 26 from the House Energy and Commerce Committee, the House is set to vote on … Continue reading
Posted in Current Affairs, FDA Policy, Legislation 1 Comment
Local Ballot Initiatives Impacting Health and Healthcare
There is a good deal of commentary about what happened at the nationally in this year’s election cycle. But a good deal happened at the state level as well – things that will impact healthcare and may influence how other … Continue reading
Posted in Legislation Comments Off on Local Ballot Initiatives Impacting Health and Healthcare
Weekly Roundup 11.4.16
We are almost through it! Just a few more days. In the meantime, the more enjoyable aspects of autumn, chilly nights, fires in the fireplace, and brilliant leaves are all upon us. Soon the end of year holidays will be … Continue reading
Posted in Warning Letters, Weekly Roundup 1 Comment