The sun sets on a summer.
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Regulatory
Qualitative Look at DDMAC NOV and Warning Letters During 1st and 2nd Quarters 2010
Posted on 01 September 2010
As reported earlier this year , the volume of regulatory action letters flowing from FDA's DDMAC continued to increase during the first half of the year at a rate that, if the trend continues, would see between 70-80 letters for the year - a substantial increase over recent years.
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Slogging Through Blogging as a Highly Regulated Industry - Some Thoughts for Pharma in the Blogosphere
Posted on 26 August 2010
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The Battle of the Bulge - New Guidances from FDA on Calories and Fast Food
Posted on 25 August 2010
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Actos Deemed as Safe as Avandia
Posted on 25 August 2010
Results from a new study reveal that patients taking Takeda’s diabetes treatment Actos have the same rate and kind of side effects as GSK’s embattled Avandia.
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The Case of the Missing Advisory Committee Transcripts…..
Posted on 24 August 2010
Usually, I love a good mystery.
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A Look at FDA’s Transparency
Posted on 16 August 2010
When Ed Koch was mayor of New York, he'd often ask a crowd “How am I doin?”
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