Two-Thirds at FDA Call Safety Guards Inadequate

It is easy to overlook the more subtle value that advisory committees can provide, said Dr. Gottlieb. “The advice we are getting is not necessarily in many cases whether or not a drug can make it to market, but the contours of the approval, what the language should look like, what indications this drug should be approved for, should it be restricted, what is an appropriate postmarket monitoring plan,” he said.