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# Improve Post-Market Evidence Generation: Report
- URL: https://www.fdaweb.com/improve-post-market-evidence-generation-report/
- Published: 2023-11-14T12:00:00.000Z
- Updated: 2026-09-14T14:16:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155792

A new Reagan-Udall Foundation report, “Enhancing Post-Market Evidence Generation for Medical Products,” addresses barriers, proposes solutions, and makes recommendations to FDA and other stakeholders that aim to facilitate evidence generation in the postmarket setting. The [report](https://reaganudall.org/sites/default/files/2023-11/Enhancing%20Post-Market%20Evidence%20Generation%20for%20Medical%20Products%20FINAL%5F0.pdf?ref=fdaweb.com) defines pragmatic evidence generation as conducting prospective clinical studies of medical products already on the market for at least one indication.

It says a pragmatic evidence generation system requires health systems, sponsors, administrative/regulatory systems, funders, payers, and FDA to:

- design pragmatic, resource-efficient studies that resolve evidence gaps and generate clinically meaningful results that affect clinical practice;
- streamline data collection as much as possible while ensuring that data quality and completeness are acceptable for regulatory purposes;
- provide opportunities and incentives to the entire patient care team to engage in pragmatic evidence generation;
- prioritize studies based on public health needs and gaps in clinical evidence; and
- engage relevant stakeholders to address who decides the priorities for knowledge generation.