Monthly Archives: August 2010

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

Slogging Through Blogging as a Highly Regulated Industry – Some Thoughts for Pharma in the Blogosphere

 According to an article published this month by eMarketer, approximately one-third of all companies now have a blog  - a number that is trending to increase to 43% of all companies in just two more years. Reasons cited include increased … Continue reading

Posted in Social Media | 4 Comments

The Battle of the Bulge – New Guidances from FDA on Calories and Fast Food

 Anyone who has ever sat in an airport waiting for a late flight – and who hasn't – may have noticed something disturbing while engaged in the healthy pursuit of people-watching.  We are increasingly a nation of fatso's.  Not long … Continue reading

Posted in Uncategorized | 3 Comments

The Case of the Missing Advisory Committee Transcripts…..

Usually, I love a good mystery.  And they are good summer reading especially.  But this one is a bit perplexing. Whenever an advisory committee serving the Food and Drug Administration has a meeting, someone has the unenviable task of transcribing … Continue reading

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Weekly Roundup – 08/20/10

 I have been temperamental on the Weekly Roundup lately.  It is only a reflection of the fact that it has been an extraordinarily busy summer.  I will persevere to be more faithful. In the meantime, here is a bit of … Continue reading

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