May 29, 2009
Oh gosh. The pollen count is off the charts. Summer storms are overanxious and overabundant. The first tropical depression has appeared off the Atlantic just prior to the official beginning of the Hurricane Season. A diabetic is ascending to the … Continue reading →
May 27, 2009
This week, the FDA issued a Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion. It is more accurately referred to as a Non-Guidance. According to FDA's DDMAC, the Internet has not really taken hold yet. … Continue reading →
May 26, 2009
Ok, last week, I ran a posting that profiled the rate of Warning and Untitled Letter rate from FDA's DDMAC, this week, let's look at the substance and see what, if any, lessons there are to be learned from DDMAC … Continue reading →
May 20, 2009
Slowly, but surely, the migration of pharmaceutical companies into new media is occurring. Given it has b een a glacial pace, and far behind other industries. FDA's DDMAC says one thing and does another when it comes to regulating the … Continue reading →
May 19, 2009
It could be the end of an era. For many years, the FDA has lacked decisive leadership and strategic vision. The agency, which was once the gold-standard of regulatory agencies, has seen that gold tarnish overtime while it … Continue reading →