Daily Archives: January 7, 2010

DDMAC Warning and NOV Letter Summary, Third and Fourth Quarters, Part 3

Posted on January 7, 2010 by Mark Senak

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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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.
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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!
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Eye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. 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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Daily Archives: January 7, 2010

DDMAC Warning and NOV Letter Summary, Third and Fourth Quarters, Part 3

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