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.
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
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What the Increasingly Granular Nature of Social Media Means for Communications
Last week I posted a few thoughts about how to get more out of medical meetings, inspired by the excellent work of some other bloggers I regularly read. Today, I’m posting a few thoughts about how communications has changed and … Continue reading
Posted in New and Social Media, Tutorial
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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
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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