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US FDA Developing Database Of Medical Review Decisions, Gottlieb Tells Congress

 
• By Brenda Sandburg

'Knowledge management platform' will identify agency's scientific precedents; Commissioner Gottlieb says it is one of FDA's top three initiatives, along with continuous manufacturing and real-time safety monitoring.

FDA entrance sign 2016

The US FDA is building a system to gather the experience of its medical review staff, Commissioner Scott Gottlieb announced at a House appropriations hearing on the agency's proposed fiscal year 2019 budget.

This "knowledge management platform" will enable FDA to store and manage the collected experience of medical review staff and have a way to identify how decisions are made across different...

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