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US FDA IT Modernization Plan Will Lay Groundwork For Real-Time Data Submissions

 
• By Sue Sutter

Principal deputy commissioner Amy Abernethy cites IND safety reporting and oncology review pilot program as areas that would benefit from enabling receipt of sponsor data in real time; plan describes near-term strategy for modernizing agency’s technical infrastructure, developing technology tools around regulatory ‘use cases’ and improving collaborations with data and tech companies.

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The FDA is working to modernize the use of technology in the regulatory process. • Source: Shutterstock

The US Food and Drug Administration’s new information technology modernization plan will help ensure the agency has the technical capabilities necessary to receive sponsor data and make regulatory decisions in real time, principal deputy commissioner Amy Abernethy said.

The plan also lays the groundwork for greater engagement between the FDA and technology and data companies, Abernethy said.

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