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# Real-World Evidence Framework is ‘Good Foundation’: Merck
- URL: https://www.fdaweb.com/real-world-evidence-framework-is-good-foundation-merck/
- Published: 2019-02-06T12:00:00.000Z
- Updated: 2026-09-15T01:00:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143312

Merck says the FDA *Framework for FDA’s Real-World Evidence Program*, which fulfills the 21st Century Cures Act requirement for the agency to establish a program to evaluate potential use of real-world evidence to help support approval of a new indication for a drug approved under section 505(c) and to help support or satisfy post-approval study requirements “provides a good foundation for exploring the full potential of real-world evidence for regulatory decision making and welcomed insight on FDA’s current views on this important topic.” The company’s comment [letter](https://www.regulations.gov/document?D=FDA-2018-N-4000-0003&ref=fdaweb.com) offers suggestions to strengthen the framework to **(1)** clarify how real-world evidence might meet the evidentiary requirements for regulatory decisions; **(2)** identify and strengthen opportunities for shared learning under the Framework; and **(3)** explore demonstration projects.

ISPOR, the professional society for health economic and outcomes research, [congratulates](ttps://www.regulations.gov/document?D=FDA-2018-N-4000-0009) FDA for producing a comprehensive implementation outline for its real-world evidence program. It says that real-world data and real-world evidence “are key building blocks to understanding real-world usage and effects of pharmaceutical products.” The society also provides specific comments on sections that are particularly relevant to its members’ mission.