October 31, 2006
What happens when the FDA decides on new policies during the course of a clinical trial? Last week, Replidyne and Forest Laboratories reported that the FDA issued a non-approvable letter for Faropenem, an antibiotic. The FDA wanted further clinical studies … Continue reading →
October 25, 2006
One might ask oneself why, if an important conference in which there is a high level of interest is just a few weeks away, have details not been announced. The answer may be that most of us assumed that the … Continue reading →
October 18, 2006
Back in July, FDA’s Dr. Scott Gottlieb gave a speech in which he talked about an upcoming conference on clinical trial design to be held in November. Word has it that the conference is going to be on the 13th … Continue reading →
September 12, 2006
Some time ago, it became apparent that the FDA was going to participate in a conference on adaptive clinical trials. Dr. Scott Gottlieb, MD, Deputy Commissioner for Medical and Scientific Affairs, Food and Drug Administration — gave a speech on … Continue reading →
August 14, 2006
From Toronto. Last night, the XVI International AIDS Conference opened in Toronto, Ontario. It is now a biennial conference and it is my sixth, having attended Florence, Amsterdam, Berlin, Vancouver and Geneva previously. For what it is worth, like the … Continue reading →