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. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
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 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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Category Archives: Tutorial
Join Me for a Webinar – Communications Implications of the Sunshine Act Data
I don’t usually do adverts here on the blog – in fact never, but you may remember a posting I did a few months back on the communications implications of the Sunshine Act implementation. There is room to be expansive … Continue reading
Posted in Tutorial, Useful Resources Comments Off on Join Me for a Webinar – Communications Implications of the Sunshine Act Data
The U.S. Pharmacopeia – What is it? What Does it Do?
One of the most frequent searches I see that people perform when coming to Eye on FDA is this – "Are Canadian Drugs Safe"? And safety, in this day and age, is the name of the game. As I've … Continue reading
When Does FDA Extend a PDUFA Date?
Today Eisai Inc. issued a press release entitled "Eisai Announces Extension of FDA Review of Drug Application for Investigational Agent Eribulin Mesylate". The company sites the reason for the extension is "a result of the agency classifying recent responses to … Continue reading
Posted in FDA Policy, Tutorial 1 Comment
What is PDUFA?
I used to have a much beloved co-worker who was not in healthcare, but upon hearing the term "PDUFA" – standing for the Prescription Drug User Fee Act – for the first time during a meeting, shouted out "What the … Continue reading
Posted in PDUFA, Tutorial 2 Comments