QSN Archives - Quality Solutions Now (QSN)

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’s New Guidance on “Alternative Tools” for Manufacturing Facility Assessments: What Life Sciences Companies Need to Know
The FDA issued a new guidance on the use of “alternative tools” for assessing manufacturing facilities as part of the drug and biologics approval process. This guidance, titled "Alternative Tools for Assessing Manufacturing Facilities Named [...]
FDA Issues Draft Guidance on 510(k) Transfer Protocols for Biotech and MedTech Firms
In June 2025, the U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance that clarifies the process for transferring ownership of 510(k) clearances. The document: “Transfer of a Premarket Notification (510(k)) Clearance” addresses [...]