About the Author
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. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.Stay Connected
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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!About This Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York 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 2021
What They Said – Overview of FDA Press Releases for 2020
Well. They said a lot. A lot more than ever, as one might expect. This past year, FDA issued a whopping 420 press releases, more so by far than any year previously. COVID certainly made a big impact – a … Continue reading
Posted in Current Affairs, FDA Image, FDA Policy
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Approvals in the Crazy Year of 2020
Each year in January, it is relevant to look back on the activities of FDA during the course of the previous year and look at how it was the same or different from prior years, and to look at trends … Continue reading
Posted in Advisory Committee Prepapartion, FDA Image, FDA Policy
Tagged #pharma, Drug Approvals
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