Life Sciences Archives

What Global Manufacturers Need to Know About 2026 UDI Enforcement

Life Sciences, Medical Devices, Unique Device Identification

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

Drug & Biologic Product Submissions, Drug Label Research, Life Sciences, Pharmaceutical and Cosmetics

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

Drug & Biologic Product Submissions, Drug Label Research, Life Sciences, Pharmaceutical and Cosmetics

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

Drug & Biologic Product Submissions, Drug Label Research, Life Sciences, Pharmaceutical and Cosmetics

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

Life Sciences, Medical Device Safety and Quality, Medical Devices, Pharmaceutical and Cosmetics, Unique Device Identification

Understand how the US government shutdown affects FDA operations and how LexisNexis supports healthcare readiness.

FHIR and the Future of Labeling

Drug & Biologic Product Submissions, Drug Label Research, Life Sciences, Medical Devices, Pharmaceutical and Cosmetics, Unique Device Identification

Learn how manufacturers can adopt FHIR to modernize labeling, enhance traceability, and meet evolving regulatory expectations.

Reflecting on RAPS Euro Convergence 2025: Regulatory Innovation in Motion

Drug & Biologic Product Submissions, Life Sciences, Medical Device Safety and Quality, Medical Devices, Pharmaceutical and Cosmetics

Global supply chain shifts can jeopardize regulatory labeling. Learn how LexisNexis Reed Tech helps manufacturers stay compliant through agile, localized labeling solutions.

Shifting Manufacturing? Don’t Let Tariffs Disrupt Your Labeling Compliance

Drug & Biologic Product Submissions, Life Sciences, Pharmaceutical and Cosmetics

Global supply chain shifts can jeopardize regulatory labeling. Learn how LexisNexis Reed Tech helps manufacturers stay compliant through agile, localized labeling solutions.

ESG NextGen Is Coming: Key Milestones, Blackout Dates & What You Need to Know

Drug & Biologic Product Submissions, Life Sciences, Medical Device Safety and Quality, Medical Devices, Pharmaceutical and Cosmetics

As part of ongoing enhancements to streamline data exchange and compliance processes, the ESG NextGen platform is preparing to go live this spring. We’re sharing a quick overview of the key milestones and what they mean for you especially as we approach the submission blackout period from April 12 to April 14, 2025.

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Recent Blogs

What Global Manufacturers Need to Know About 2026 UDI Enforcement

FDA Final Rule: Preparing for the Transition to a 12-Digit NDC

FDA Finalizes Guidance on Promotional Labeling for Biologics and Biosimilars

Printed Drug Labeling Requirements Remain in Effect

30 Days Into the U.S. Government Shutdown: What It Means for the FDA and for You

FHIR and the Future of Labeling

Reflecting on RAPS Euro Convergence 2025: Regulatory Innovation in Motion

Shifting Manufacturing? Don’t Let Tariffs Disrupt Your Labeling Compliance

ESG NextGen Is Coming: Key Milestones, Blackout Dates & What You Need to Know

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