Can 'Moon Shot' Lift FDA Out Of Its Silos?
This article was originally published in Scrip
Executive Summary
Even though the White House's "moon shot" initiative is focused on cancer, a key component of the program – a new multimillion-dollar FDA "virtual" center for excellence intended to expedite the development and regulatory review of new combination therapies – may be the force to lift the agency out of its silos so that drugs, devices and diagnostics intended to be used together for other types of diseases are not forced to undergo time-consuming separate assessments, said Ellen Sigal, founder and chair of the advocacy group Friends of Cancer Research (FOCR).