October 17, 2007
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 →
October 15, 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 →
October 10, 2007
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 →
October 5, 2007
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 →
October 3, 2007
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 →