Regulatory Strategy Archives - Quality Solutions Now (QSN)

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 [...]
FDA Pauses Submissions Amid Government Shutdown: What You Can Do Now
The start of October 2025 brought an unusual complication for the life sciences industry - a partial U.S. government shutdown that has significantly limited FDA operations. With much of the agency’s staff on furlough and [...]
RAPS Convergence 2025: What to Expect at the Premier Regulatory Affairs Event
Starting today, October 6th, and ending on October 7th, regulatory professionals from around the world will gather in Pittsburgh, Pennsylvania for RAPS Convergence 2025, the go-to conference for insights, networking, and future-focused discussions in medical [...]
FDA to Phase Out Animal Testing Requirements, Promising Accelerated Cures and Smarter Drug Development
In April 2025, the U.S. Food and Drug Administration (FDA) unveiled their roadmap designed to reduce, refine, and potentially replace animal testing, beginning with monoclonal antibody therapies and expanding to other drug modalities. This marks [...]