TL;DR What Happened? The recalled product is Baxter 0.9% Sodium Chloride Injection USP, 500 mL VIAFLEX Plastic Container, involving identified lots distributed July 31 through August 3 to multiple U.S. states. The company says the potential contaminant was identified as fiberglass. Customers should discontinue use and return affected units. Why…
TL;DR What FDA Changed FDA’s Recognition List Number 066 modifies the list of voluntary consensus standards it recognizes for use in medical-device regulatory work. The Federal Register notice explains that manufacturers may use recognized standards and declarations of conformity to help address certain premarket requirements. CDRH listed the update among…
TL;DR FDA says GE reported that during an update of Portrait Core Services software, some patients monitored using Portrait Mobile devices were discharged removed from the monitoring system. FDA also says alarm settings may reset to factory defaults following the update. That creates the possibility that the hardware appears operational…
FDA’s 4th draft guidance revision streamlines biosimilar PK testing, allowing non-U.S. comparators with analytical justification to cut $20M costs and speed approvals.
Explore why 76% of healthcare AI pilots stall due to regulatory gaps in HIPAA, EU AI Act, FDA rules. Learn compliance strategies and governance best practices for safe scaling.
Explore how Vinay Prasad’s resignation from FDA’s CBER amid regulatory clashes disrupts pharma profits, rare disease approvals, and vaccine strategies. Analyze impacts, compliance shifts, and future enforcement.
Google reports 48% of 2025 zero-days targeted enterprise software—an all-time high. Explore regulatory requirements, compliance obligations, and critical security measures organizations must implement.
Explore how state laws are challenging federal pre-emption in escrow and product labeling, turning compliance into a major risk factor for businesses amid Supreme Court scrutiny.
Discover how transforming regulatory checks into a 13:1 ROI shields businesses from $20K fines and operational chaos. Learn proven strategies to calculate non-compliance tax costs and unlock compliance value.
IRS Notice 2026-15 clarifies material assistance from prohibited foreign entities for clean energy tax credits under Sections 45Y, 48E, 45X. Understand MACR calculations, safe harbors, PFE definitions, and compliance steps.
