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Recent Blogs
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
Swissmedic Launches UDI Module in swissdamed
Swissmedic has launched the UDI module in swissdamed, marking a key step in Switzerland’s medical device regulation. Voluntary submissions begin in August 2025, with mandatory registration starting July 2026. The system aligns with EUDAMED standards to enhance traceability, compliance, and post-market surveillance.
Navigating the TGA’s Phased Introduction: What Class III & IIb Device Sponsors Need to Know
Australia’s Therapeutic Goods Administration (TGA) is taking a phased approach to regulatory compliance, prioritizing higher-risk medical devices first and gradually expanding requirements to lower-risk categories in the coming years. This structured rollout is designed to manage the complexity of implementation while ensuring that patients and healthcare systems benefit from stronger safeguards at the earliest possible stage.