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FDA Faces More Tech Hurdles After Clearing AERs Backlog, And Congress Is Watching

 
• By Sarah Karlin-Smith

Congressional scrutiny of FDA’s overall document management challenges is unlikely to let up despite the agency’s clearing of its adverse event reports backlog. Rep. Michael Burgess hit FDA’s document management practices hard during the first formal hearing on the 21sy Century Cures initiative.

Processing all backlogged paper drug adverse event reports signals technological achievement for FDA, but the agency’s overall IT and digital picture may not be improving at the desired speed and Congress is taking note.

The agency on May 27 said additional data entry staff and process-re-engineering allowed it to clear the paper reports backlog...

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