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Recent Blogs
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.
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.