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 2010
Applause for FDA’s New FDA Basics Initiative
Today the FDA launched what is being billed as the "first phase of its transparency initiative" which is less about transparency than providing a sound educational footing for how the FDA operates. It is much welcomed, and long overdue. The … Continue reading
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EU Moves Slowly to Enhance Patient Information on RX Products
In the United States, the long-standing culture of direct-to-consumer (DTC) advertising, provides the primary basis by which patients are informed about both conditions and treatments. It is controversial, with many on either side of the debate finding little middle ground. … Continue reading
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Weekly Roundup – 1/8/10
We are eight days into the New Year. I don't know about you, but I'm not seeing much different that I like. Getting back into the grind of things though. Healthcare reform is behind us. Now we face the reform … Continue reading
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DDMAC Warning and NOV Letter Summary, Third and Fourth Quarters, Part 3
Two days ago, we examined the number of enforcement actions by DDMAC and yesterday we looked at what tripped regulatory wires to result in a Notice of Violation (NOV) letter. Today, we're going to look Warning Letters and examine some … Continue reading
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DDMAC Warning and NOV Letter Summary, Third and Fourth Quarters, Part 2
Yesterday there was a quantitative look at the Warning Letters and Notice of Violation (NOV) etters that showed that after years of decline in enforcement, there is no uptick in DDMAC's issuance of these regulatory letters. Today, the qualitative aspects … Continue reading
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