Category Archives: Clinical Trials

Clinical Trials and Social Media – Part 1 in an Intermittent Series

Last week Brian Reid wrote an excellent piece on the Common Sense blog entitled “The 5 Consequences of the Lack of FDA Social Media Guidance“.  He got off to a great start, but I actually think there are many more … Continue reading

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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:

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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

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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

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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

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