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Presence Of Patient Experience Data Table In FDA Drug Review Summaries ‘Inconsistent’

 
• By Cathy Kelly

RTI Health Solutions researchers assessed US FDA review documents over past two years to gauge use of a tool meant to facilitate agency disclosures about what patient experience information it considered.

Medical technology, telemedicine, e-health, medical online, electronics health record system concept. male doctor working on digital tablet computer with web icons technology on virtual screen.
A Patient Experience Data Checklist For Review Summaries

The US Food and Drug Administration is making progress with its implementation of a patient experience data summary section in new drug review documents but there are still inconsistencies, RTI Health Solutions' Ari Gnanasakthy reported at ISPOR's recent annual meeting.

The patient experience data table outlines whether and what patient experience data had been submitted with an application. The FDA began using the table in 2017 to help meet a requirement established by the 21st Century Cures Act that the agency publicly state what patient experience data it reviewed in applications submitted after 12 June 2017

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