FDA nearing ‘holy grail’ of drug review, Gottlieb says

In an article written for BioCentury, former FDA Commissioner Scott Gottlieb says the agency is “on the cusp of a major cultural shift” that will transform the way it reviews drugs.

The convergence of new thinking at FDA, advances in digital technologies, and especially a boost in congressional funding have set the stage for a fundamental change in the drug review paradigm, according to Gottlieb, a resident fellow at the American Enterprise Institute. ...