FDA Launches Web-Based Tobacco Premarket Application Forms to Enhance Submission Process
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...
FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment
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...
Current Food Production Methods
This Issue of the Month reviews modern food production methods and evolving manufacturing technologies, highlighting regulatory and food safety considerations manufacturers should evaluate as processing systems, automation, and supply chain practices continue to evolve.
Drug and Device Corner 2025 November
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...
FSVP Tips to Navigate Common Pitfalls
This Issue of the Month provides practical guidance for companies implementing the FDA’s Foreign Supplier Verification Program (FSVP), outlining common compliance pitfalls and steps importers can take to strengthen documentation, supplier oversight, and food safety compliance.