Monthly Archives: October 2006

Antibiotics and Clinical Trials

Posted on October 31, 2006 by Mark Senak

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

Anemic Report from PhRMA on DTC Accountability

Posted on October 30, 2006 by Mark Senak

In 2005, PhRMA created a set of DTC Guidelines for industry putting forth a number of principles by which signatories would abide in fashioning direct-to-consumer ads.  The report recently issued by PhRMA on that account leaves much to be desired. … Continue reading →

Posted in DTC Advertising | 2 Comments

Weekly Roundup – 10/27/06

Posted on October 27, 2006 by Mark Senak

Hey, what can I say?  It has been a dull week.  Other than finding out that the conference on adaptive clinical trial design appears to be private, it has been really a no-news week.  I am sad about the conference.  … Continue reading →

Posted in Weekly Roundup | 2 Comments

The Cold War

Posted on October 26, 2006 by Mark Senak

Recently Congressman Henry Waxman (D-CA) has been involved in correspondence with Acting Commissioner Andrew C. von Eschenbach.  He wrote on August 23, September 22 and now again on October 23.  It seems to be a monthly thing. His concern is … Continue reading →

Posted in FDA Policy, OTC Switches | Comments Off on The Cold War

Is the Adaptive Clinical Trials Workshop a Private Affair?

Posted on October 25, 2006 by Mark Senak

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?