Real-Word Evidence Generation System Will Be A Priority For Califf As FDA Commissioner

15 Dec 2021

At his Senate confirmation hearing, Robert Califf said he wants to establish a system, built on electronic medical records, that can be used to more quickly confirm the benefits and risks of accelerated approval drugs.

Robert Califf at Senate HELP confirmation hearing 14 December 2021 (screenshot) — Robert Califf offered thoughts on how to speed the confirmation of accelerated approvals during his own confirmation hearing. • Source: Screenshot

Establishing the framework for a systematic approach to real-world evidence generation that would allow for quicker confirmation of the benefits and risks of accelerated approval drugs, among other uses, will be a key priority for Robert Califf if confirmed as the next US Food and Drug Administration commissioner.

During his 14 December confirmation hearing before the Senate Health, Education, Labor and Pensions Committee, Califf said an evidence generation...