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Recent Blogs
What Global Manufacturers Need to Know About 2026 UDI Enforcement
In 2026, medical device manufacturers face mandatory UDI enforcement across the European Union (EUDAMED), Australia (AusUDID), and Switzerland (Swissdamed). Regulators are shifting from system rollout to active compliance oversight, requiring continuous data maintenance, alignment between labeling and database records, and audit-ready transparency. Global manufacturers must implement centralized UDI governance and lifecycle management strategies to reduce regulatory risk and maintain market access.
FDA Final Rule: Preparing for the Transition to a 12-Digit NDC
The FDA’s final rule standardizes National Drug Codes into a uniform 12-digit format beginning March 7, 2033. Pharmaceutical manufacturers, distributors, and healthcare stakeholders must prepare systems, labeling, serialization, and supply chain integrations during the transition period through 2036 to ensure compliance and avoid disruption.
FDA Finalizes Guidance on Promotional Labeling for Biologics and Biosimilars
The FDA has finalized guidance on promotional labeling and advertising for biologics, biosimilars, and interchangeable biosimilars, clarifying expectations to ensure communications are accurate, truthful, and not misleading across all media.
Printed Drug Labeling Requirements Remain in Effect
Understand how the US government shutdown affects FDA operations and how LexisNexis supports healthcare readiness.
30 Days Into the U.S. Government Shutdown: What It Means for the FDA and for You
Understand how the US government shutdown affects FDA operations and how LexisNexis supports healthcare readiness.
How a Government Shutdown Impacts the FDA and Healthcare Industry
A government shutdown forces the FDA to scale back operations, delaying new drug and device approvals and slowing healthcare innovation. Learn what continues, what pauses, and why prolonged disruptions matter for patients and providers