Changing the global policy

Regulatory NewsRegulatory News | 06 February 2020 |  By 

US Food and Drug Administration (FDA) Commissioner Stephen Hahn addressed FDA staffers in an all-hands meeting for the first time on Thursday, explaining how he wants to do more with real-world evidence (RWE), which has been a controversial subject.

While noting that FDA is operating in a time of “unsurpassed scientific and technological innovation,” Hahn called to unleash the power of data and “to attain more and better data,” according to a transcript of his speech. The comments build upon the agency’s technology modernization plan unveiled last September.

“By harnessing this power, we can improve our regulatory decision-making and more effectively connect today’s groundbreaking scientific discoveries with the rapid development and approval of new products. We can also increase the knowledge patients and consumers have to make informed decisions about FDA-regulated products,” he said.

Hahn also continued to push the agenda of his predecessor, Scott Gottlieb, who released an RWE framework in December 2018. Although the agency has only used RWE in limited amounts so far.

“Specifically, I believe there is great promise in the effective use and integration of patient-level data or real-world evidence such as electronic health records, clinical trials, medical studies, and patient registries,” Hahn said.


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