FDA Makes More Use of Patient Experience Data for Approvals, Report Says

July 2, 2021

The FDA is increasingly using patient experience data when approving new drugs or biologics, but the agency’s use of the data “varies widely,” an agency-commissioned report has concluded.

Of 120 new drug and biologics applications assessed, the FDA used patient-reported outcome data in its reviews 84 percent of the time and clinician-reported outcome data 33 percent of the time, according to the report by the Eastern Research Group (ERG).

But many drugmakers complained to ERG about being unable to regularly meet with FDA officials to discuss patient experience data during product development. And the research firm recommended that the agency allocate more time for these meetings.

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