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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.
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 is taking a decisive step to revoke the authorization for the use of Food, Drug & Cosmetic Red No. 3 in food and ingested drugs.
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.
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 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.
The U.S. Food and Drug Administration (FDA) announced today, October 31, 2024, that it has approved a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS). This modification aims to provide patients and caregivers with a free, pre-paid drug mail-back envelope from outpatient pharmacies or other dispensers of opioid analgesics.
As most drug companies are aware of at this point, the CARES Act requires drug manufacturers to report annual production amounts to the FDA. This requirement has been rolling out over the course of 2024 and, here at LexisNexis Reed Tech, we are receiving many questions from our customers have had questions about how to meet these requirements.
Navigating the Evolving Landscape of Medical Device Regulations and Digital Transformation