Drug and Device Corner March 2025
The 2025 OMUFA facility user fees have been announced in the Federal Register (see link below). Facility User Fee Rates FY 2025 Monograph Drug Facility (MDF) Fee $37,556 Contract Manufacturing Organization (CMO) Fee $25,037 The background and legislation on this...
Understanding the Role of Your U.S. Agent
Foreign entities who operate in US FDA-regulated industries must have an appointed FDA US agent before they can import products into the US. At a minimum these FDA US agents provide the most basic of required services. However, agents with relevant experience and knowledge can provide much more.
Drug and Device Corner February 2025
Reminder that CARES volume reports for 2024 are due no later than 31 March 2025. If you need assistance with the process, EAS is here to help. The FDA has updated the OTC MONOGRAPHS @ FDA website’s OTC Monograph Resources section. This includes a digital Catalogue of...
Drug and Device Corner January 2025
Effective January 20, 2025, The President issued a Regulatory Freeze Executive Order, which will have a direct impact on regulated industries. The regulatory freeze order, consistent with the actions of previous incoming administrations, effectively halts any...