Apr 28, 2025 | Drug and Device Corner, Drugs, Medical Devices
Under GDUFA, human generic drug facilities, sites, and organizations are required to submit identification information electronically to FDA annually. These submissions are made during the month of May The following types of generic industry facilities, sites, and...
Apr 8, 2025 | Cosmetics, Drug and Device Corner, Drugs, Medical Devices
We want to keep our clients up to date as we learn of any changes at the FDA that will affect normal business processes. The following 3 points have come to our attention in the last few days. For any questions regarding the status of a product in the NDC Directory,...
Mar 25, 2025 | Drug and Device Corner, Drugs, Medical Devices
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...
Feb 26, 2025 | Drug and Device Corner, Drugs, Medical Devices
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...
Jan 29, 2025 | Drug and Device Corner, Drugs, Medical Devices
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...
Dec 31, 2024 | Drug and Device Corner, Drugs, Medical Devices
The FDA issued a final rule establishing requirements for a nonprescription drug product with an Additional Condition for Nonprescription Use (ACNU). This new marketing pathway will allow the sale of a nonprescription drug product directly to a consumer once the user...
