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# Understanding FDA Patient Experience Data Use
- URL: https://www.fdaweb.com/understanding-fda-patient-experience-data-use/
- Published: 2019-10-15T12:00:00.000Z
- Updated: 2026-09-15T01:56:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145257

Of 59 new molecular entities approved by FDA in 2018, 48 included a table summarizing whether patient experience data (PED) was used during the agency drug review. Some 71% of the 48 approvals reported using PED in the review, with patient-reported outcomes the most significant source of PED.

Sanofi researchers say they are reporting on use of PED as a first step to better understanding how the agency considers PED in regulatory decision making. “This analysis should help develop a baseline regarding FDA use of PED and may inform decisions to ensure patients’ experiences are adequately heard in future drug development,” the researchers [write](https://journals.sagepub.com/doi/pdf/10.1177/2168479019871519?ref=fdaweb.com) in *Therapeutic Innovation & Regulatory Science*.

The article says that going forward, the authors expect that FDA review divisions’ use of a table describing PED use would become more standardized. They also discuss the format of the public statement required under the 21st Century Cures Act.