“Considerable Concern” at FDA About Avandia

Pharmalot has a good overview of the situation, though I question the wisdom of declaring it “AvandiaGate” at this stage. Addition: DrugWonks has an interesting excerpt from the Glaxo submission.

–BC

(As usual: I do a small amount of work for pharmaceutical clients.  I have not represented Glaxo, though I’ve had clients be co-defendants with them.)