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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Category Archives: FDA
FDA Discusses News Reports That the Agency has Withheld Information on Chinese Manufacturers of Heparin from Congress
In February 2008, the FDA announced that heparin, a blood thinning agent, was not going to be manufactured voluntarily by its U.S. manufacturer because of serious adverse events. The adverse events were tied by FDA to a contaminant discovered that … Continue reading
Rather late this year, the FDA has posted the tentative dates for advisory committee meetings for 2008. Right now, except for meetings that have already been announced, these are primarily "save the date" reservations so that the many experts on … Continue reading
Hi there. I know I was taking this week off for vacation, but it hasn’t worked out that way. After a quick trip to the family, a 14 hour return drive, instead of R&R, I’m working again. So here is … Continue reading