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: August 2011
Hello? Anyone out there? I send out a group email and get back scores of automated replies thanking me for my email and telling me when the recipient will be back in the office. I feel like the only person … Continue reading
It has been a while since providing an update on legislative proposals introduced in Congress that would impact the FDA, medical products and food industries. With Congress out on recess, it seemed like a good time to catch up on … Continue reading
A break in the weather with cooling temps and a Congress out of session made Washington a more bearable place this week. Still, recovering from what has been the Bummer Summer may take a while and require some more salve. … Continue reading
Earlier this week, we examined the Warning and NOV letters that came from FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC). Today we’re going to look at a few of the communications lessons learned from same – and reminding … Continue reading