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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Category Archives: New and Social Media
FDA OPDP Research – A Foggy Window into Future Thinking on Digital Media
When one thinks of FDA’s Office of Prescription Drug Promotion (OPDP) there is a likely tendency to think of the regulatory action letters – Warning Letters or Untitled Letters -issued by that office to pharmaceutical companies about their promotional communications. … Continue reading
Posted in New and Social Media
Tagged Digital Health, FDA, Social Media
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Pharma, FDA and Web Site Mobilization
In 2009 FDA set up the framework outlining its approach to regulating promotional speech by pharmaceutical companies by posing five questions for discussion during a two-day public meeting the agency held in Washington, D.C. Rather than issue a single guidance … Continue reading
Posted in New and Social Media, Social Media
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Is FDA Running Out of Juice on Social Media?
FDA held a public meeting in April 2009 on the regulation of promotional speech on social media by medical product manufacturers and set the framework for the discussion (and the subsequent regulation) by asking five questions. Ostensibly guidance was to … Continue reading
Posted in New and Social Media, Social Media
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What Pharma’s Are Doing on Periscope – Update on the Landscape
If you have Periscope on your phone, you may find yourself doing something and all of a sudden, hear a little whistle that is the sound cue to let you know that someone you follow has gone live. I set … Continue reading
Posted in New and Social Media, Social Media
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Up Scope! Pharma, Periscope and Some Regulatory Questions
Back in June in a posting about the new (relatively) live streaming capability brought to use by Periscope. The app, acquired by Twitter prior to its launch early in 2015, allows you to live stream content from where you are to … Continue reading
Posted in New and Social Media
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