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: November 2010
Warning Letter Summary thru Third Quarter 2010, Part 2 – the Qualitative Look
A few weeks back, I posted the third quarter numerical report on Warning Letters and Notice of Violation letters issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC). In that accounting, I reported that there were a … Continue reading
Posted in Uncategorized
1 Comment
FDA Launches Proposed New Packaging for Cigarettes
Not much has changed in the cigarette packaging world since the now familiar warning from the Surgeon General appeared on the side of a pack reminding you that smoking can be harmful to your health. That was 45 years ago. … Continue reading
Posted in FDA Policy
1 Comment
Does Record of Product Recalls Reveal Increases During Obama Administration?
This morning during my commute to work (5.5 miles), I received 5 email notices regarding product recall notices. FDA recall notices include FDA and company generated news about any product that is under the FDA's jurisdiction, which is of course … Continue reading
Posted in Uncategorized
3 Comments
Weekly Roundup – 11/05/10
A collective sigh of relief comes to us all this week as the cycle of candidate commercials comes to an end. I just want to say – we did not approve this message. One thing is for sure, candidates and … Continue reading
Posted in Uncategorized
1 Comment
The Election is Over – Is There an FDA Impact?
Probably. As the results from yesterday's election are digested by various parts of the nation, for those of us with an eye on FDA, one has to wonder if there is any direct impact on the future of the agency … Continue reading
Posted in Uncategorized
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