Brad Jordan, Senior Director, Regulatory Policy, submitted comments on behalf of Flatiron Health to the U.S. Food and Drug Administration on the recent Draft Guidance: Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products. Flatiron welcomed the release of this foundational draft guidance and applauded the FDA for its efforts to advance the use of RWD/E in regulatory-decision making. The key points are highlighted below. The full letter is available for download at this link.
- Health technology organizations should be included in FDA’s Advancing RWE Program.
- The FDA should adopt a risk-based approach to study-specific verification and validation.
- We encourage the FDA to exercise the appropriate regulatory flexibility needed to support the use of RWE in regulatory decision-making.
- Health technology organizations, sponsors and the FDA should work together to align on appropriate data-quality guidelines applicable to sources of RWD.