New Biotech Working Group at FDA seeks modern, flexible regulatory framework

Detailing his agency’s efforts to advance biotech innovation, US Food and Drug Administration Commissioner Scott Gottlieb has outlined key areas in which he intends to develop FDA policies and practices.

In a blog post, Dr Gottlieb said it was “key that the FDA adopt a regulatory approach... that’s as innovative and nimble as the opportunities that we’re tasked with evaluating.”

In the key growth area of cell and gene editing, he said the FDA was focused on expeditiously translating technologies from animal research models to products intended for use in humans.