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
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
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
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
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
