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Recent Blogs
Missed FDA Annual Deadlines? It’s not too late to correct your listings!
The Food and Drug Administration (FDA) requires drug manufacturers to keep their listings updated each year. Most of...
FDA Updates Guidance on GUDID and GMDN Codes: What You Need to Know
Explore the FDA’s update on GUDID, focusing on the transition to GMDN Codes for device identification. Learn how to adapt to these changes efficiently.
FDA to Revoke Authorization for Red No. 3 in Food and Drugs
FDA is taking a decisive step to revoke the authorization for the use of Food, Drug & Cosmetic Red No. 3 in food and ingested drugs.
Webinar Recap | Comply with Pharma Year-End Deadlines: 2024 Mandate Update
This webinar provides a comprehensive overview of pharma year-end reporting obligations, including blanket no-change certification options and new OTC Monograph mandates, the timelines for reporting and the process for submitting reports to the FDA.
EUDAMED Questions Answered; Navigating the Gradual Roll-Out of EUDAMED under MDR and IVDR Updates
Last week, the European Commission released a Q&A on practical aspects related to implementing the gradual roll-out of EUDAMED. In the following blog, we will cover highlights from the document and recommendations for the next steps.
Health Canada Announces Mandatory Use of XML Product Monograph in 2025
Health Canada is introducing the mandatory use of the extensible markup language product monograph (XML PM) in phases, with the first phase taking effect on July 18, 2025. This initial phase will require certain submission types to include the XML PM at the time of filing.