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Recent Blogs
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.
Pharmaceutical Industry Top Innovators
Explore the key Pharmaceutical Innovators revealed in the latest Innovation Momentum report and their impact on the industry.
FHIR and the Future of Labeling
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
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
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
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.
Health Canada’s Progress on Implementing the XML Product Monograph Requirement
Health Canada continues to make strides in modernizing the way pharmaceutical product information is structured and shared. As part of its digital transformation efforts, the agency is advancing the implementation of the XML Product Monograph (XML-PM) requirement, which is set to enhance efficiency, accessibility, and interoperability of drug labeling information across the industry.