The U.S. Food and Drug Administration (FDA) has issued an important safety communication regarding blood pressure…
Category: US
US / FDA updates on medical device regulation and quality.
FDA to Publish Complete Response Letters in Real-Time: New Policy Transforming Regulatory Transparency
The U.S. Food and Drug Administration (FDA) has announced a significant shift in its regulatory communication…
FDA Warns Against Imported Cookware Linked to Dangerous Lead Contamination
The U.S. Food and Drug Administration (FDA) has issued a critical update urging both retailers and…
FDA Introduces Green List to Prevent Unsafe GLP-1 Drug Imports
The U.S. Food and Drug Administration (FDA) has launched a significant regulatory measure aimed at curbing…
FDA Signals Urgent Catheter Packaging Defect: Abbott’s Updated Guidance for TactiFlex Ablation Users
The FDA has recently issued an early alert highlighting a critical concern with Abbott’s TactiFlex Ablation…
FDA Greenlights Expanded Pediatric and Adult Use of Vonvendi for von Willebrand Disease
The U.S. Food and Drug Administration (FDA) has announced its approval for the expanded use of…
Voluntary Recall Issued for Olympus ViziShot 2 FLEX 19G Needles Due to Safety Concerns
Olympus Corporation has announced a voluntary global recall of specific lots of its ViziShot 2 FLEX…
FDA Targets Misleading Drug Ads with New Compliance Initiative
The U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS)…
FDA Highlights Safety Alert for Abiomed’s Impella Controllers Due to Purge Retainer Issue
The FDA has issued an early alert regarding a significant safety concern with Abiomed’s Automated Impella…
FDA Launches Guidance to Advance Non-Opioid Chronic Pain Solutions and Battle Opioid Misuse
The U.S. Food and Drug Administration (FDA) has announced a major step in addressing the opioid…