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Posted 14 November 2018 | By Zachary Brennan 

Woodcock Pushes for Major Digital Shift in Regulation

Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, made clear on Tuesday that there needs to be a major shift in regulatory toward a more digital world.

“The time has come that we think about digital tech in a new way to streamline and use the digital age to effectively regulate and efficiently regulate,” Woodcock said at the Friends of Cancer Research annual meeting Tuesday.

She noted that regulators around the world are currently using digital forms of paper, or PDFs, which can still be burdensome.

FDA’s Oncology Center of Excellence is already leading this digital push, she noted, as OCE has a project tied to the investigational new drug application (IND) phase whereby instead of writing up every adverse event and submitting it in a paper format, turning it into a PDF and then sending in a submission – companies can submit the adverse event directly to the FDA’s Adverse Event Reporting System(FAERS).

Woodcock also noted that the clinical trial enterprise is ripe for digital disruption.

“If you look at the clinical drug development enterprise – there’s a vast amount of time spent on legacy approaches – most of this is not a high return on investment,” she said.

“My modest proposal is we get together and think forward on how to move to enable the digital age to help clinical investigations,” she added. “We rely too much on digital versions of paper – and need to take this new approach internationally” so sponsors are not submitting different information to different regulators. “The more we can move to standardize and digitize data,” the better off the industry will be, she noted.


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