SPOTLIGHT: FDA to take closer look at Phase IV trials


The FDA is beginning a year-long review of its Phase IV drug trials. Regulators want to look closely at how the post-marketing drug trials are designed and implemented with clear rules for drug companies. The agency has been embarrassed by reports showing that the majority of Phase IV drug trials agreed to by drug companies during the approval process are simply dropped. Regulators insist that they aren't examining how the agency tracks these studies through completion, but how carefully they're designed. Report