FDA’s new Tobacco center put out 14 Warning Letters to internet purveyors of candy cigarettes. FDA seems very serious about not letting flavored cigarettes onto the market. Now about menthol….
The Center for Drugs also issued a doozy of a Warning Letter to a clinical trial site in Southern California. Among the shortfalls are: failure to supervise the investigation and numerous protocol violations. Also, the investigator failed to have the IRB approve changes in research activity. New protocol amendments showed additional hazards and risks associated with the study drug but the investigator said nary a word to the IRB. That’s a Warning Letter in and of itself. Finally, the investigator was creamed on failure to report Serious Adverse Events as instructed by the protocol. It appears to me that some of these SAEs are disease progression. It may be a case of the sponsor writing violations unnecessarily into the protocol. However, in this case we have a textbook case of the investigator not doing the job.