Jan 2, 2026 | Issue of the Month
Artificial intelligence is quickly finding its way into quality systems across pharmaceutical, medical device, food, and dietary supplement operations. While AI tools offer clear potential to improve efficiency, trend analysis, and decision-making, they also raise important questions about data integrity, validation, and regulatory oversight.
Dec 22, 2025 | Drug and Device Corner, Drugs, Medical Devices
Reminder that if the 31 December registration renewal deadline is missed, drug and medical device facility registrations will drop off the public databases. Registrations can be reactivated with a successful renewal submission. Any NDC drug listings that miss the...
Dec 3, 2025 | FDA and USDA Regulatory Update, Tobacco
The FDA’s Center for Tobacco Products (CTP) has introduced new web-based versions of key forms used for PMTA and Substantial Equivalence (SE) Report submissions. These updated forms are now available through CTP Portal Next Generation (NextGen), the agency’s enhanced...
Dec 2, 2025 | FDA and USDA Regulatory Update
The U.S. Food and Drug Administration has announced a significant expansion of its internal artificial intelligence capabilities through the deployment of agentic AI tools across the agency. The new system is designed to help FDA staff manage complex, multi-step tasks...
Dec 1, 2025 | Foods, Issue of the Month
Current Food Production Methods By Lane Highbarger, EAS Consulting Group Independent Consultant The past 50 years of research in microbiological pathways have taught us much about genes and the resultant protein products. The discovery of restriction enzymes in the...
Nov 24, 2025 | Drug and Device Corner, Drugs, Medical Devices
For those not already aware, the US government shutdown has ended. The User Fee system is now open and accepting FY2026 payments. The first step for renewal of your Medical Device facility is to pay the FDA FY2026 Medical Device Annual Establishment Registration User...
