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: Social Media
To Tweet or Not to Tweet? Or Even Retweet? FDA, Tweeting and Twitter
On June 27, FDA approved a new product – a rapid acting inhaled insulin indicated for the treatment of diabetes call Afrezza. The agency announced the approval by sending out a press release. The agency also sent out this tweet: … Continue reading
Posted in Social Media
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Developing a Policy for Correcting Third Party Misinformation
Last week I held my Webinar on FDA’s Regulation of Social Media called “In More than 140 Characters…” During the 1 hour presentation, I attempted to cover a lot of ground, wanting not only to focus on the latest two … Continue reading
Posted in Social Media
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Collection of FDA and Social Media Resources
Many years have passed since FDA began attempting to enunciate a regulatory approach to digital and social media – beginning in 2009 and still presumably on-going. In June the most substantive guidance yet was released by the agency addressing two … Continue reading
Posted in FDA Policy, Social Media
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Guidance on Two Social Media Fronts from FDA’s OPDP
For four and half years now FDA’s OPDP has endeavored to devise answers to 5 questions raised during a public hearing on the Internet, Social Media and Pharma and Device Manufacturers held in April 2009. Finally, on a day when … Continue reading
Posted in Social Media
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Looking Beyond Patient Engagement for Pharma and Social Media
As we wait for the anticipated guidance from FDA regarding the use of social media by the pharmaceutical industry, one of the many aspects discussed as been that of patient engagement with the industry. The Internet is highly utilized for … Continue reading
Posted in Social Media
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