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: September 2015
FDA Adds a New AdComm for Patients
This week FDA published a Federal Register announcement stating that the agency was establishing a new Patient Engagement Advisory Committee designed to provide counsel to the Commissioner on issues related to medical devices. The agency said that the scope is … Continue reading
Posted in Advisory Committee Prepapartion, FDA Policy
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Weekly Roundup 9.18.15
For those of us hungry for it, we had our first taste of autumn. It has been lovely to sleep with windows open. Granted the long shadows appear earlier than they used to and the sun is setting from a … Continue reading
Posted in Weekly Roundup
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Then and Now – Shutdown Showdown
The last time we faced a government shut down, there were some advance communications on how various government agencies were going to be operating during the “event”. Last time, the executive brand had issued a memorandum on September 17, this … Continue reading
Posted in FDA Policy
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Weekly Roundup 9.11.15
Today we remember those lost, honor those living who were there to help and dedicate ourselves to a goal of peace. Here is a bit of what happened this past week that I thought noteworthy: NIH Announces Landmark Blood Pressure … Continue reading
Posted in Weekly Roundup
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More on Twitter and Pharma
Before breaking for summer vacation, I had posted about the increase in Twitter followers among pharma companies this year over last and noted that the overall number of Twitter followers of pharma feeds had increase significantly. That was true despite … Continue reading
Posted in Social Media
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