RWE Archives - Quality Solutions Now (QSN)

FDA’s “One Pivotal Trial” Default: What It Means for Evidence Quality, Not Just Speed
On February 18, 2026, FDA leadership signaled a major shift in how effectiveness is demonstrated for most drugs: the default expectation will be one adequate and well-controlled pivotal study, paired with confirmatory evidence, rather than [...]
Inside FDA’s “TEMPO” Pilot
FDA closed out 2025 - and opened the door to 2026 - with a clear signal to digital health and medical device sponsors: real-world performance of digital technologies is no longer a future consideration, it’s [...]
FDA Finalizes Real-World Evidence Guidance for Medical Devices: What It Means (and How to Use It)
FDA closed out 2025 with a meaningful update for device sponsors: the final guidance, “Use of Real-World Evidence (RWE) to Support Regulatory Decision-Making for Medical Devices,” issued December 18, 2025, which supersedes the prior 2017 [...]