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...
Nov 10, 2025 | Foods, Issue of the Month
FSVP Tips to Navigate Common Pitfalls By Brandon Boone, EAS Consulting Group Independent Consultant Since the implementation of the FDA’s Foreign Supplier Verification Program (FSVP) in 2017, overall compliance rates have remained consistently low. There are a wide...
Oct 28, 2025 | Drug and Device Corner
REMINDER: We are in the drug registration renewal and listing certification period, do schedule your renewal/certification prior to the 31 December 2025 deadline. Facilities that manufacture OTC monograph drugs are reminded that the data pulled for assessing FY2026...
