Category Archives: Tutorial

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

Posted in Podcast, Tutorial | Comments Off

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

Social Media Tools and Strategy – A Webinar Coming Up

I was at a talk not long ago where two questions were posed by the speaker to the audience.  First was – how many people have cell phones?  Naturally everyone in the room raised their hand.  The second question was … Continue reading

Posted in New and Social Media, Tutorial | 2 Comments