LexisNexis Reed Tech
Explore our library of blogs, short videos, virtual event recordings and training topics
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
Navigating drug and device regulations isn’t optional—it’s mission-critical. This Regulatory Survival Guide breaks down the complexities of global compliance, from FDA and EU MDR to Health Canada, UDI, and MoCRA. Whether you’re managing submissions or facing upcoming deadlines, use this FAQ to decode key terms, avoid costly risks, and stay ahead with expert-backed solutions like Compliance-as-a-Service (CaaS).
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.
The Food and Drug Administration (FDA) requires drug manufacturers to keep their listings updated each year. Most of the deadlines fall on December 31st. What happens if a manufacturer misses these deadlines? In most cases, the drug is in danger of becoming inactive....
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.
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.
On Tuesday, October 15, 2024, Reed Tech and 1WorldSync hosted a highly informative webinar led by Gary Saner, Senior Regulatory Principal at Reed Tech, and Scott Brown, Senior Director of Global Data Strategy at 1WorldSync. The webinar focused on how their continued alliance helps companies navigate Unique Device Identification (UDI) management and utilize the Global Data Synchronization Network (GDSN) to meet regulatory compliance requirements.