About the AuthorMy 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.
My ProfileI 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: January 2011
Weekly Roundup – 1/28/11
Well, we had a winter of no snow. Then on Wednesday they said it would start at 4 o’clock. At precisely 4 PM I looked out my office window and darn if it didn’t begin to snow – the heavy … Continue reading
Posted in Weekly Roundup 1 Comment
The FDA Guidance System Needs a Fix
Back in March 2010, in a posting on the FDA’s Transparency Blog – the FDA asked the question “How Can FDA Improve the Guidance Process.” The responses in the form of comments to the posting are primarily made up of … Continue reading
Posted in FDA Policy 1 Comment
Weekly Roundup 1/21/11
It has been a nearly snow-less winter here in Washington, in contrast of course to last winter when I was housebound for nearly a week. Let me just say, I find neither of these extremes particularly desireable…. More importantly, here … Continue reading
Posted in Uncategorized Comments Off on Weekly Roundup 1/21/11
DDMAC Warning and NOV Letters – LookBack for 2010
FDA’s Division for Drug Marketing, Advertising and Communications (DDMAC) is responsible for regulating the communications by medical product manufacturers with the public about their products. During 2010, the agency issued 52 letters, which is more than during any year since … Continue reading
Posted in Warning Letters 1 Comment