May 23, 2011
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 →
September 20, 2010
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 →
August 30, 2010
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 →
July 26, 2010
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
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February 9, 2010
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 →