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: July 2010
The Day After – the FDA Avandia Meeting
The Thursday morning quarterbacking begins! Actually I did not attend the meetings. I did, however, thanks to eagle eye buddy Brian Reid (@brianreid) who gave the heads up on Twitter that CNN was actually running video of the meeting (unprecedented … Continue reading
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Should There be an App for Reporting Adverse Events?
Today the United States Department of Agriculture (USDA) announced the launch of a new app for smartphones that will alert consumers to the latest recall information in one spot, allowing them to track and actually see recalled products. This means … Continue reading
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IOM – Ethical Issues in Studying Safety of Approved Drugs
Just as an FDA Advisory Committee is mixing a batch of Avandia soup at a hearing held today to discuss and review the post-marketing safety of the drug, the Institute of Medicine (IOM) has issued a letter report on the … Continue reading
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The XVIII International AIDS Conference – Everything Has Changed
Next Sunday the opening session of the XVIII International AIDS Conference will take place in Vienna, Austria. The conference, which used to be an annual conference and is now biannual, will bring together clinical research scientists, social scientists, health educators … Continue reading
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A Food and Drug Administration Facebook Page?
For a long time, I have been an advocate for the FDA to open up a Facebook page. There are a lot of reasons, but first and foremost is a recognition that social media has changed the way we communicate … Continue reading
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