The U.S. Food and Drug Administration (FDA) announced the appointment of Tracy Beth Høeg, M.D., Ph.D.,…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
FDA Issues Early Alert on Glucose Monitor Sensor Risks from Abbott Diabetes Care
The FDA has issued an Early Alert regarding a significant safety concern involving certain glucose monitor…
Critical Update: Olympus Modifies Use Instructions for Single Use Ligating Device PolyLoop
On December 3, 2025, the FDA announced a significant correction related to Olympus’s Single Use Ligating…
Swissmedic Expands Therapeutic Indication for Welireg®
Swissmedic, Switzerland’s medical regulatory authority, has announced an extension of the approved therapeutic indication for the…
FDA Proposes New Measures to Minimize Non-Human Primate Testing for Monoclonal Antibody Development
The U.S. Food and Drug Administration (FDA) has released proposed guidance aimed at reducing or eliminating…
FDA’s Coordinated Crackdown: $1 Million Worth of 7-OH Opioids Seized in Missouri
The U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Department of Justice (DOJ),…
Swissmedic Opens Recruitment for Experienced Software Architect in Regulatory IT
Swissmedic, Switzerland’s key authority for the oversight of therapeutic products, has recently issued a call for…
Swissmedic Opens Role for Cloud Engineering Expertise in Medical Device Regulation
Swissmedic, Switzerland’s authority for medical devices and therapeutic products, announces an exciting cloud engineering position. Key…
FDA Rolls Out Advanced AI Tools for Enhanced Regulatory Operations
The U.S. Food and Drug Administration (FDA) has announced a significant milestone: the organization is deploying…
FDA Issues Urgent Recall for SJM Pericardial Patch Due to Quality Control Issue
An urgent recall has been announced for a specific lot of SJM Pericardial Patch devices distributed…