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: January 2018
The funding kerfuffle came and went. Order was restored to the universe after a brief blip shuttered federal agencies, FDA among them, for a single work day. It almost seems like a distant memory already, until next time. The weather … Continue reading
Keeping our eye on FDA press releases as one measure of the way FDA talks to us is a regular feature here on Eye on FDA and there is no better time to look back than when we begin a … Continue reading
As noted below, next week the Senate HELP Committee will hold Part 2 of a hearing series on public health threats in the 21st Century. Ironically this comes at the same time we are facing a series of deadlines to … Continue reading
Yesterday, Commissioner Scott Gottlieb announced a new effort on the part of the agency aimed at increasing transparency around clinical trials, a goal long sought by many patient advocates, particularly outside the U.S. Specifically, FDA is introducing a pilot program … Continue reading