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. ┬áThere is room to be expansive … Continue reading

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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. ┬áToday, I’m posting a few thoughts about how communications has changed and … Continue reading

Posted in New and Social Media, Tutorial | 4 Comments

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

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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