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.
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 BlogEye 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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Monthly Archives: March 2007
This Weekly Roundup did not come soon enough for me! And yet it is hard to believe that the first quarter of 2007 is over. Next week, I’ll do the look back at the Warning Letters for the quarter. But … Continue reading
As per the posting earlier this week about the EMEA, and in preparation for an upcoming trip to the U.K., I’ve been reading and comparing the Web sites of the FDA with the EMEA. It provides some interesting points that … Continue reading
The FDA is between a rock and a hard place when it comes to PDUFA. The Prescription Drug User Fee Act provides a great deal of funding by which the agency can afford to engage in a wide range of … Continue reading
A lot of the commentary about the recently proposed changes to the FDA’s Advisory Committee rules for participation centered on the mysterious limit of $50,000 applied to the interests of members in industry. Where did that figure, many have asked, … Continue reading