Category Archives: Clinical Trials

Adolor Corp. Gets Approvable Letter

Today Adolor Corp. announced receipt of an approvable letter from the FDA requesting 12-month safety data that includes an analysis of any cardiovascular related adverse events.  The application was for Entereg, indicated for the management of postoperative ileus.  Share this:

Posted in Clinical Trials | Comments Off on Adolor Corp. Gets Approvable Letter

Adaptive Clinical Trials Workshop – An Opportunity Gone South

Back in July when Dr. Scott Gottlieb made a speech before the American Medical Association and made a lengthy reference to a November workshop in which FDA would participate regarding adaptive clinical trials, there was a great deal of anticipation … Continue reading

Posted in Clinical Trials | 1 Comment

Antibiotics and Clinical Trials

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

Posted in Clinical Trials | 1 Comment

Is the Adaptive Clinical Trials Workshop a Private Affair?

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

Posted in Clinical Trials | Comments Off on Is the Adaptive Clinical Trials Workshop a Private Affair?

Waiting for Word on the Adaptive Clinical Trials Workshop

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

Posted in Clinical Trials | Comments Off on Waiting for Word on the Adaptive Clinical Trials Workshop