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: June 2009
Is FDA Picking Up the Regulatory Pace?
It seems early in the oversight of the new FDA Commissioner and Deputy Commissioner to the agency turning a corner, or maybe not. There have been two indications of possible increased enforcement that have emerged in the past few days … Continue reading
Posted in FDA Policy
1 Comment
Weekly Roundup – 6/26/09
We have had 3 days in a row without rain. That is most welcome. Today, I fear, we may lose our streak. It has heated up in Washington and so has the debate on healthcare reform. Another public figure who … Continue reading
Posted in Weekly Roundup
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Opps for Apps
It is no state secret that the pharmaceutical industry is seriously lagging behind other industries – even other highly regulated industries – in making use of digital media to engage and support their stakeholders. There are still many, if not … Continue reading
Posted in New and Social Media
5 Comments
FDA’s Transparency Meeting
Tomorrow, the FDA is holding a hearing on transparency here in Washington, D.C and have issued their ground rules for participation. The event is certainly a noble gesture and one does not have reason to expect that this time around, FDA is anything … Continue reading
Posted in FDA Policy
1 Comment
The Growing Importance of Twitter
I happen to think that no element of new and emerging media is more important than Twitter – something that should be apparent to anyone involved in communications. Enter into evidence the role that Twitter played in many recent news … Continue reading
Posted in New and Social Media
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