In an exclusive interview, Janet Woodcock, head of the Center for Drug Evaluation and Research (CDER) at the US Food & Drug Administration (FDA) outlines how the world's gold-standard agency for regulatory science is adapting to game-changing and often extremely expensive new therapies, why a sizeable impact from data and artificial intelligence on the US drug approval process is still some way in the future, and how the FDA is collaborating with other regulators in an increasingly globalised system of drug development and approval.
We have worldwide citizenship obligations. As we did with ICH, we are trying to bring everybody up to a certain level and be fit for purpose
