Monthly Archives: October 2007

FDA Approves New Merck HIV Medication

Yesterday the FDA announced a new drug approval for the treatment of HIV.   Bucking the FDA’s recent inclination to approvable letters, the approval of Isentress (raltegravir) brings a first-in-class treatment known as integrase strand transfer inhibitors to the armentarium of … Continue reading

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Warning Letter Summary – 3rd Quarter 2007

Following last week’s chart displaying the quantitative overview of FDA’s DDMAC issuance of Warning Letters and Untitled Letters, I wanted to begin this week with a qualitative perspective on what those letters covered.   Since there are so few letters, it … Continue reading

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Less Equals More

Here is a brief update on the pattern of Warning Letters issued by DDMAC to companies for violations in promotion.  As you can see, the numbers under the Bush Administration have seriously declined, as pointed out frequently here on this … Continue reading

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Weekly Roundup – 10/05/07

Well, autumn inside the nation’s first-city is getting off to a difficult start, made more so by a complete lack of rain that makes it look as if they only autumn color is going to be brown.  One can’t even … Continue reading

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A Conversation with Jim Greenwood – BIO CEO and President

The newly passed legislation in Congress that will reform FDA and reauthorize the Prescription Drug User Fee Act for another five years is just one example of dynamic change that is occurring in the marketplace.  This week, I was able … Continue reading

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