FDA Guidance: A Privacy-First Approach To Using Real World Evidence For Regulatory Decision Making

By Doug Fridsma

Privacy preserving linking technologies have matured rapidly in recent years, and provide solutions to linking data that were not possible even a few years ago. The FDA guidance on the use of real world data in regulatory decision-making — coupled with other parallel innovations on how the industry conducts clinical trials — will take the industry closer to a future state where it is possible to augment gold standard clinical trials with linked, longitudinal RWD, to support the ongoing safety and efficacy of drugs, devices, and diagnostics in the marketplace.

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